Robotic rod benders and related mechanical and motor housings

ABSTRACT

A robotic rod bender is disclosed. The robotic rod bender includes an autoclavable top assembly that includes a rod feeding subassembly, a brake subassembly, and a bending subassembly. The rod bending subassembly, the bending subassembly, and the brake assembly are disposed on a top plate. The robotic rod bender also includes a motor housing that includes one or more motors, a spline shaft, and a linear actuated elevator assembly. The linear actuated elevator assembly includes a linear actuator, a movable plate, and a mid-plate. The spine shaft extends from the moveable plate. The autoclavable top assembly is removably disposed atop the mid-plate.

RELATED APPLICATIONS

This application is a non-provisional application, which claims thebenefit of priority as a continuation-in-part from U.S. application Ser.No. 16/560,422 which is a Continuation-in-part of U.S. patentapplication Ser. No. 16/183,980 filed on Nov. 8, 2018, which claimspriority to provisional application Ser. No. 62/583,851 filed on Nov. 9,2017. The disclosures of both of the above referenced applications arehereby incorporated herein in their entireties by reference.

FIELD

The present disclosure relates to medical devices, and moreparticularly, surgical robotic systems for bending surgical rods, andrelated methods and devices.

BACKGROUND

Spinal fusion is a surgical procedure used to correct deformity of thespine by fusing together the painful part of the spine in order torestrict its motion and relieve painful symptoms. Spinal fusion surgeryis commonly utilized to treat abnormal spinal curvatures, such asscoliosis and abnormal kyphosis, for example, degenerative discdiseases, spondylolisthesis, trauma resulting in spinal nervecompression, vertebral instability caused by infections or tumors, andother conditions.

Fusion surgery may include the placement of rods and screws usinginstrumentation and/or the placement of bone graft in between thevertebrae. During surgery, the surgeon may correct the deformity of thespine so as to ensure that the radiographic parameters of the spine inboth the sagittal and coronal plane fall within clinically acceptedvalues. While doing so, the surgeon fixes the corrected spine into placeusing metallic rods. The rods need to conform to the shape of the spineand hence need to be bent accordingly.

Currently, devices such as French bender and power bender are utilizedin the operation room in order to bend the rods to the desiredcurvature. However, these devices require cumbersome manual processes tooperate. In addition, use of these devices to bend the rod may alsointroduce notches on the rod, which may decrease the rod's fatigue life.

SUMMARY

According to some embodiments, provided herein is a robotic rod bender.The robotic rod bender may include an autoclavable top assembly. Theautoclavable top assembly may include a rod feeding subassemblyconfigured to feed a surgical rod. The autoclavable top assembly mayfurther include a brake subassembly configured to receive the rod fromthe rod feeding subassembly and fix the surgical rod in place. Theautoclavable top assembly may further include a bending subassemblyconfigured to bend the surgical rod while the surgical rod is fixed inplace by the brake subassembly. The rod bending subassembly, the bendingsubassembly, and the brake subassembly may be disposed on a top plate.The robotic rod bender may further include a motor housing including oneor more motors configured to drive the autoclavable top assembly. Themotor housing may further include a spline shaft. The motor housing mayfurther include a linear actuated elevator assembly, wherein the linearactuator elevator assembly may include a linear actuator, a movableplate driven by the movable plate, and a mid-plate above movable plate.The spline shaft may extend from the moveable plate. The t least one ofthe motors may be connected to the moveable plate. The autoclavable topassembly may be disposed atop the mid-plate. The linear actuatedelevator assembly may provide automatic positioning of one or morecomponents of the motor housing with the autoclavable top assembly.

According to additional embodiments, provided herein is a motor housingfor a robotic rod bender. The motor housing may include a motor, aspline shaft, and a linear actuator elevator assembly. The linearactuated elevator assembly may include a mid-plate. The linear actuatedelevator assembly may further include a movable plate below themid-plate, wherein the motor is connected to the moveable plate, andwherein the spline shaft extends from the moveable plate. The linearactuated elevator assembly may further include a cam assembly thatincludes a cam, a roller, and a cam engagement bar. The roller may beconnected to the movable plate, wherein the cam engagement bar isconnected to a top plate. The roller may be configured to move inconjunction with the movable plate. The roller may be further configuredto contact and rotate the cam, thereby causing the cam to engage withand lock onto the cam engagement bar. The roller may be furtherconfigured to continue to move in a straight line along the longitudinalaxis. The roller may facilitate automatic piercing of a drape andengaging the spline shaft through the mid-plate. The linear actuatedelevator assembly may further include at least one pair of linear railspositioned in parallel alignment with one another, wherein the linearrails are disposed along the longitudinal axis of the motor housing,wherein the linear rails are configured to facilitate movement of themoveable plate in an upward and a downward direction. The linearactuated elevator assembly may further include a linear actuatorremovably attached to the movable plate, wherein activation of thelinear actuator is configured to lift the movable plate upward along thelongitudinal axis.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this application, illustrate certain non-limiting embodiments ofinventive concepts. In the drawings:

FIG. 1 illustrates a view of a robotic bending system to automaticallybend a surgical rod, according to some embodiments;

FIG. 2 illustrates a view of a bending robot of the robotic bendingsystem of FIG. 1 , according to some embodiments;

FIG. 3 illustrates a partially disassembled view of the bending robot ofFIG. 2 , according to some embodiments;

FIG. 4 illustrates an internal view of components of a bending robotaccording to an alternative embodiment;

FIG. 5 illustrates components of a rod feeding subassembly of thebending robot of FIG. 4 , according to some embodiments;

FIG. 6 illustrates components of a brake and cutting subassembly of thebending robot of FIG. 4 , according to some embodiments;

FIG. 7 illustrates components of a bending subassembly of the bendingrobot of FIG. 4 , according to some embodiments;

FIG. 8 illustrates a side view of the components of the bending robot ofFIG. 4 , according to some embodiments;

FIG. 9 illustrates components of a rod feeding subassembly for a bendingrobot according to another alternative embodiment;

FIGS. 10A-D illustrate surgical rods having removable sterile sleeves,according to some embodiments;

FIGS. 11A and 11B illustrate components of a bending robot according toanother alternative embodiments;

FIG. 12 is a flowchart of a method of operating a bending robot,according to some embodiments;

FIGS. 13 and 15 provide illustrations of a Rod Bender System without adrape according to some embodiments;

FIGS. 14 and 16 provide illustrations of a Rod Bender System with adrape according to some embodiments;

FIG. 17 illustrates an exploded view of a rod bender system according tosome embodiments;

FIGS. 18A, 18B, and 18C illustrate examples of mechanical couplingsbetween mechanical and motor housings according to some embodiments;

FIG. 19 illustrates an example of a mechanical coupling providingself-centering according to some embodiments;

FIG. 20 illustrates a pin that can be used to lock a mechanical couplingaccording to some embodiments;

FIG. 21 illustrates a bottom surface of a mechanical housing accordingto some embodiments;

FIG. 22 illustrates a top surface of a motor housing dissembled from amechanical housing according to some embodiments;

FIG. 23 illustrates an exploded view of a rod bender system according tosome embodiments;

FIG. 24 illustrates a sterile mechanical housing with a flange andinternal side gasket according to some embodiments;

FIG. 25 illustrates a rod bender system providing engagement betweenmechanical and motor housings using a locking mechanism according tosome embodiments;

FIG. 26 illustrates a rod bender system with a fenestrated drapeaccording to some embodiments;

FIG. 27 illustrates springback in a rod after bending according to someembodiments;

FIG. 28 illustrates a rod bender system configured to determinespringback for a rod according to some embodiment;

FIGS. 29A and B illustrate examples of a rod bender capture probetip/handle assembly according to some embodiments;

FIGS. 30A and 30B illustrate examples of a rod bender capture probetip/handle assembly including a stray marker according to someembodiments;

FIGS. 31A and 31B illustrate examples of a rod bender capture probetip/handle assembly including a stray marker according to some otherembodiments;

FIGS. 32A, 32B, and 32C illustrate examples of probe tips that interfacewith instruments such as the spinal screw of FIG. 32D according to someembodiments;

FIG. 33 is a screen shot showing transformation points in two orthogonalplanes (e.g., the sagittal plane and the coronal plane) corresponding toa patient's anatomy according to some embodiments;

FIG. 34 is a screen shot showing adjustments to the transformationpoints of FIG. 33 in the two orthogonal planes according to someembodiments;

FIG. 35 is a screen shot showing a use of orthogonal fluoroscope imagesto construct a bend plan according to some embodiments;

FIG. 36 is a screen shot showing merging of multiple bend plans to for amerged plan according to some embodiments;

FIG. 37 illustrates use of a bend at the end of the rod toreduce/prevent movement of the rod;

FIG. 38 illustrates markings on the rod according to some embodiments;

FIG. 39 illustrates a cap on an end of the rod according to someembodiments;

FIG. 40 is a block diagram illustrating a controller according to someembodiments of inventive concepts;

FIGS. 41-44 are flow charts illustrating operations of the controller ofFIG. 40 according to some embodiments of inventive concepts;

FIGS. 45-53 are exploded views of elements of mechanical housings ofbending robots according to some additional embodiments of inventiveconcepts;

FIG. 54 illustrates an embodiment of an autoclavable top assembly andmotor housing without a drape;

FIG. 55 illustrates a rear view of a rod bender system comprising alinear actuated elevator system according to some embodiments;

FIG. 56 illustrates an embodiment of a linear actuator according to someembodiments of a linear actuated elevator system;

FIG. 57 illustrates an embodiment of a cam system according to someembodiments of a linear actuated elevator system;

FIGS. 58A, 58B, and 58C illustrate various configurations of a camsystem according to some embodiments of a linear actuated elevatorsystem;

FIGS. 59A, 59B, and 59C illustrate various configurations of a plateposition corresponding to cam actuation according to some embodiments ofa linear actuated elevator system;

FIG. 60 illustrates kinematic mounts for mounting an embodiment of a topplate onto an embodiment of a mid-plate according to some embodiments ofa linear actuated elevator system;

FIGS. 61A and 61B illustrate an embodiment having a kinematic mountemploying a series of v-grooves and ball-end surfaces; and

FIG. 62 is a flowchart of a method of operating a bending robotcomprising a linear actuated elevator assembly, according to someembodiments.

DETAILED DESCRIPTION

It is to be understood that the present disclosure is not limited in itsapplication to the details of construction and the arrangement ofcomponents set forth in the description herein or illustrated in thedrawings. The teachings of the present disclosure may be used andpracticed in other embodiments and practiced or carried out in variousways. Also, it is to be understood that the phraseology and terminologyused herein is for the purpose of description and should not be regardedas limiting. The use of “including,” “comprising,” or “having” andvariations thereof herein is meant to encompass the items listedthereafter and equivalents thereof as well as additional items. Unlessspecified or limited otherwise, the terms “mounted,” “connected,”“supported,” and “coupled” and variations thereof are used broadly andencompass both direct and indirect mountings, connections, supports, andcouplings. Further, “connected” and “coupled” are not restricted tophysical or mechanical connections or couplings.

Referring now to FIG. 1 , a view of a robotic bending system 10 forautomatically bending a surgical rod intraoperatively is illustratedaccording to some embodiments. The bending system 10 of FIG. 1 includesa bending robot 100 and may also include a controller unit 102 tocontrol and/or monitor the operation of the bending robot 100 and/orother components or devices. The bending robot 100 includes a rodfeeding subassembly 104 to receive, feed, and rotate a surgical rod 106,a brake subassembly 108 to retain a first portion of the surgical rod106 at a particular position, and a bending subassembly 110 to bend asecond portion of the surgical rod 106 with respect to the first portionof the surgical rod 106 to define a bend angle between the first andsecond portions of the surgical rod 106. By feeding and rotatingadditional sections of the surgical rod 106, additional portions of thesurgical rod can be bent to form a number of different shapes suitablefor use in spinal fusion surgery or other procedures.

In this example, the controller unit 102 (also referred to as acontroller) may include a controller base 112 and a plurality ofcomponents, which may be in communication with each other and/orcomponents of the bending robot 100, as desired. For example, thecontroller unit may include a camera 114 to monitor the bending robotand/or other aspects of the surgery or procedure, an input device 116 toreceive instructions from a user before or during the procedure, and adisplay device 118 to provide visual information to a user before orduring the procedure. The robot 100 and/or controller unit 102 mayinclude one or more processor circuits (not shown) configured to executemachine-readable instructions to operate components of the bending robot100 or other components or devices.

Referring now to FIG. 2 , a more detailed view of the bending robot 100of FIG. 1 is illustrated, according to some embodiments. As shown inFIG. 2 , the bending robot 100 includes a robot housing 120 that is partof a robot base to house components of the rod feeding subassembly 104,brake subassembly 108, bending subassembly 110, and other components.The rod feeding subassembly 104 includes a rod feeding actuator 124configured to retain a surgical rod 106 therein, selectively move thesurgical rod 106 in a direction parallel to a longitudinal axis of thesurgical rod 106, and selectively rotate the surgical rod about thelongitudinal axis of the surgical rod 106. The rod feeding actuator 124includes an actuator spindle 134 with a pulley cable 136 woundtherearound, and a retaining ring 140 to retain and align the surgicalrod 106. In this example, the retaining ring 140 is sized to hold thesurgical rod 106 in place by friction, and to allow the rod to slidethrough the ring when an appropriate amount of force is applied to thesurgical rod 106. The retaining ring 140 in this example may beselectively replaced with a differently sized retaining ring toaccommodate a surgical rod having a different diameter. As will bediscussed below, a pulley subassembly (not shown) selectively advancesand rotates the surgical rod 106 to position the surgical rod 106 in acorrect location and orientation with respect to the brake subassembly108 and the bending subassembly 110. It should also be understood that,while this embodiment uses a pulley subassembly, other types of feedingactuator linkages may be used to transfer power from one or more motorsto move and/or rotate the rod feeding actuator 124.

The brake subassembly 108 includes a brake housing 142 and a brakeactuator 146 configured to receive the surgical rod 106 from the rodfeeding subassembly 104, and selectively fix a first portion of thesurgical rod 106 with respect to the brake subassembly 108. In thisembodiment, after the brake actuator 146 fixes the surgical rod 106, therod feeding subassembly 104 moves longitudinally back to its originalposition and may advance and/or rotate the surgical rod 106 furtherafter the brake actuator 146 is released.

While the brake actuator 146, is engaged, the bending subassembly 110includes a bending actuator 150 that selectively rotates about a firstrotational axis perpendicular to the longitudinal axis of the surgicalrod 106 to engage a second portion of the surgical rod 106 and bend thesecond portion of the surgical rod 106 with respect to the first portionof the surgical rod 106 so that the first portion and the second portionof the surgical rod 106 define a first bend angle. To reduce/preventnotching of the surgical rod 106 during the bending process, a pair ofroller bearings 154 positioned on either side of the surgical rod 106form the engagement points between the surgical rod 106 and the bendingactuator 150 during the bending process.

Referring now to FIG. 3 , a partially disassembled view of the bendingrobot 100 of FIG. 2 is illustrated according to some embodiments. Inthis example, a mechanical housing 121 includes mechanical components ofthe rod feeding subassembly 104, brake subassembly 108, and bendingsubassembly 110, and a motor housing 122 includes additional componentsof the bending robot 100, including a first feeding actuator motor 130,a second feeding actuator motor 132, a brake actuator motor 148, abending actuator motor 172, and/or additional internal mechanicaland/electrical components such as additional linkages and/or electronicprocessor circuits or other circuits. For example, in some examples amemory coupled to a processor circuit may include machine-readableinstructions that, when executed by the processor circuit, cause theprocessor circuit to cause the rod feeding subassembly 104 toselectively move the surgical rod and selectively rotate the surgicalrod 106, cause the brake subassembly 108 to selectively fix the firstportion of the surgical rod, and/or cause the bending subassembly 110 toselectively rotate about the first rotational axis to engage the secondportion of the surgical rod 106 and bend the second portion of thesurgical rod with 106 respect to the first portion of the surgical rod106.

The mechanical housing 121 is configured to be removably coupled to themotor housing 122 so that the first and second feeding actuator motors130, 132, brake actuator motor 148, and bending actuator motor 172 canselectively operate the rod feeding subassembly 104, brake subassembly108, and bending subassembly 110, respectively. In this example, themechanical housing 121 does not include any electrical or electroniccomponents that could be damaged by conventional preoperative orintraoperative sterilization techniques, such as autoclaving,high-temperature steam sterilization, chemical sterilization, or othertechniques. Thus, by disposing the non-sterile motor housing 122 in thesterile robot housing 120, and removably coupling the sterile mechanicalhousing 121 onto the motor housing 122, intraoperative sterility can bemaintained without needing to expose the electrical and/or electroniccomponents of the bending robot 100 to harsh sterilization techniquesthat may damage these components and may reduce the useful life of thesecomponents.

As shown in FIG. 3 , the rod feeding subassembly includes a first pulleysubassembly 126 configured to engage and be driven by the first feedingactuator motor 130, and a second pulley subassembly 128 configured toengage and be driven by the second feeding actuator motor 132. A pulleycable 136 is wound around first pulley subassembly 126 and the secondpulley subassembly 128, as well as the actuator spindle 134 of the rodfeeding actuator 124. The first pulley subassembly 126 includes a firstpulley transmission input 160 that matingly engages with a first pulleytransmission output 164 that is driven by the first feeding actuatormotor 130. The first pulley subassembly 126 also includes a secondpulley transmission input 162 that matingly engages with a second pulleytransmission output 166 that is driven by the second feeding actuatormotor 132.

In this embodiment, the directions of rotation of the first feedingactuator motor 130 and the second feeding actuator motor 132 determinethe direction of movement and/or rotation of the surgical rod 106. Forexample, to move the rod feeding actuator 124 in a longitudinaldirection along a longitudinal rail subassembly 138 toward the brakesubassembly 108 and bending subassembly 110, the first feeding actuatormotor 130 rotates counterclockwise and the second feeding actuator motor132 rotates clockwise. Similarly, to move the rod feeding actuator 124in a longitudinal direction along the longitudinal rail subassembly 138away from the brake subassembly 108 and bending subassembly 110, thefirst feeding actuator motor 130 rotates clockwise and the secondfeeding actuator motor 132 rotates counterclockwise. To rotate theactuator spindle 134 in a clockwise direction, the first feedingactuator motor 130 rotates clockwise and the second feeding actuatormotor 132 also rotates clockwise. To rotate the actuator spindle 134 ina counterclockwise direction, the first feeding actuator motor 130rotates counterclockwise and the second feeding actuator motor 132 alsorotates counterclockwise.

The brake actuator 146 is configured to engage and be driven by thebrake actuator motor 148. The brake actuator 146 includes a worm gear158 having a brake transmission input 168 that matingly engages with abrake transmission output 170 that is driven by the brake actuator motor148. Driving the worm gear 158 causes a brake gear arm 156 to engageand/or disengage the brake actuator 146 to selectively fix or releasethe surgical rod 106. In this example, selective operation of the brakeactuator motor 148 in a first rotational direction when the brakeactuator 146 is in a neutral position causes the brake gear arm 156 tomove the brake actuator 146 from the neutral position to an engagedposition to selectively fix the first portion of the surgical rod 106with respect to the brake subassembly 108. Similarly, selectiveoperation of the brake actuator motor 148 in a second rotationaldirection opposite the first rotational direction when the brakeactuator 146 is in the engaged position causes the brake gear arm 156 tomove the brake actuator 146 from the engaged position to the neutralposition to selectively release the surgical rod 106. In this example,the brake subassembly 108 is a brake and cutting subassembly thatfurther includes an internal blade mechanism (not shown), whereinselective operation of the brake actuator motor 148 in the secondrotational direction when the brake actuator 146 is in the neutralposition causes a blade of the internal blade mechanism to cut thesurgical rod 106. In this example, two internal plates may be slid apartin a reverse scissoring motion, introducing tension to the rod in twodifferent directions and trimming the excess. It should also beunderstood that an alternative or additional brake actuator linkage maybe used in place of or in addition to the worm gear 158 and brake geararm 156 of the brake subassembly 108.

Similar to the rod feeding subassembly 104 and the brake subassembly108, the bending actuator 150 of bending subassembly 110 includes abending transmission output (not shown) that matingly engages with abending transmission input 174 that is driven by the bending actuatormotor 172, and that transfers power from the bending actuator motor 172through a bending actuator linkage (not shown) to drive the bendingactuator 150. Thus, when the sterile mechanical housing 121 is removablycoupled to the motor housing 122 in the sterile robot housing 120, thebending robot 100 is able to automatically bend the surgical rod 106 inreal-time in a sterile, intraoperative environment. Following each bend,the previously fixed portion of the surgical rod 106 may be advancedand/or rotated by the rod feeding subassembly 104 and another portionmay be fixed by the brake subassembly 108. The bending subassembly 110then bends the previously fixed portion of the surgical rod 106, and soon, until the rod is bent to a desired shape and can be cut and used aspart of the spinal fusion surgery or other procedure.

Referring now to FIGS. 4-7 , components of a bending robot 400 accordingto an alternative embodiment are illustrated. As shown by FIG. 4 , thebending robot 400 in this embodiment includes a rod feeding subassembly404, a brake and cutting subassembly 408, and a bending subassembly 410.As shown by FIGS. 4 and 5 , the rod feeding subassembly 404 includes arod feeding actuator 424 that is selectively longitudinally movable androtatable via a first pulley subassembly 426 and second pulleysubassembly 428. A first feeding actuator motor 430 and a second feedingactuator motor 432 transfer power through the first pulley subassembly426 and second pulley subassembly 428 via a pulley cable 436 to move theactuator spindle 434 along a longitudinal rail subassembly 438 androtate the actuator spindle. The actuator spindle 434 includes aremovable retaining ring 440 to retain and align the surgical rod (notshown) therein.

As shown by FIG. 4 , the brake and cutting subassembly 408 includes abrake housing 442 having a retaining ring 444 similar to the retainingring 440 of the rod feeding subassembly 404, to receive and align thesurgical rod. A brake actuator 448 is controlled by a brake actuatormotor 448 to selectively fix and/or release the surgical rod. As shownby FIG. 6 , the brake actuator 446 includes a brake gear subassemblyincluding a brake gear 482. In this example, the brake gear is coaxialwith, but independently rotatable with respect to, the main gear of thebending gear subassembly 452. This arrangement is to conserve internalspace, but it should be understood that other mechanical arrangementsmay be used to achieve the same or similar functionality. In thisexample, rotating the brake gear 482 causes the brake gear arm 456 torotate in a first direction from a neutral position, wherein thesurgical rod can be freely moved and rotated with respect tothrough-hole 484, to an engaged position, wherein the brake gear armrotates to compress the surgical rod within the through-hole and fix thesurgical rod in place. In this embodiment, rotating the brake arm fromthe neutral position in an opposite direction causes a blade of aninternal blade mechanism (not shown) to cut the surgical rod.

Referring now to FIG. 7 , the bending subassembly 410 includes a bendingactuator 450 controlled by a bending actuator motor 472 via a bendinggear subassembly 452. A pair of roller bearings 454 are configured toengage the surgical rod when the bending actuator 450 is rotated to bendthe surgical rod to a predetermined bend angle.

FIG. 8 illustrates a side view of the components of the bending robot400 of FIG. 4 . As shown by FIG. 8 , the components of the bending robot400 in this example are coupled to an upper support structure 476 and alower support structure 478 coupled to and spaced apart from the uppersupport structure 476, to provide structural support for the componentsof the bending robot 400 while allowing for easier access to thecomponents of the bending robot 400 for maintenance and repair, forexample.

Many techniques are available to sterilize and reduce/preventcontamination of a surgical rod being bent in an intraoperativeenvironment. For example, the embodiment of FIGS. 2 and 3 includes aremovable mechanical housing 121 that can be completely sterilized usingconventional sterilization techniques without risking damage to theelectrical or other components of the separate motor housing 122. Inanother example illustrated in FIG. 9 , a bending robot 900 includes arod feeding subassembly 904 and a bending subassembly 910 to feed,rotate and bend a surgical rod 906. In this example, the bending robot900 includes integrated computing components, including an integrateddisplay 918, to control the bending robot 900.

In the embodiment of FIG. 9 , a sterile drape 988 may cover thenon-sterilized components of the bending robot 400, with sterilizedcomponents being coupled to the non-sterilized components via magneticconnectors 990, 994 of the sterilized components matingly coupling tocomplementary magnetic connectors 992, 996 (e.g., male-femaleconnections) of the non-sterilized components, with motion of thecomponents being transferred through the drape 988. While magneticconnections are used in this embodiment, it should be understood thatother connections, such as a tight-fit mechanism that allows fortransferring mechanical motion without compromising the integrity of thedrape 988, may be used. For example, in this and other embodiments, therotatable components do not require a range of motion of more than 180degrees. Because of this relatively small range of rotation, using atight fit mechanism is possible without tearing or otherwise undulystraining the drape 988.

In some embodiments, a sterile surgical rod may be sealed within asterile sleeve or wrap, which is then bent intraoperatively in anon-sterile environment. In this regard, FIGS. 10A-D illustrate surgicalrods having removable sterile sleeves as illustrated, according to someembodiments. Referring to FIG. 10A, a sterile surgical rod 1006 iswrapped in a spiral sterile wrap 1098 material. Following bending of thesurgical rod 1006, the spiral sterile wrap 1098 may be removed and thesterile surgical rod 1006 may be delivered into the sterileintraoperative environment.

Similarly, FIG. 10B illustrates another sterile surgical rod 1006′having a sterile sleeve 1098′ that may be peeled away from the sterilesurgical rod 1006′ following bending of the sterile surgical rod 1006′.FIGS. 10C and 10D illustrate a sterile surgical rod 1006″ disposed in asterile flexible shaft 1098″, which is sealed at either end by removablecaps 1099. A bending robot in a non-sterile environment may beconfigured to bend the flexible shaft 1098″, thereby bending the sterilesurgical rod 1006″ within the flexible shaft 1098″ without contacting orcontaminating the sterile surgical rod 1006″.

Following the bending process, the sterile surgical rod 1006″ may beremoved from the flexible shaft 1098″ and delivered into the sterileintraoperative environment. In these and other embodiments, thecoverings for the sterile surgical rods 1006, 1006′, 1006″ may have auniform outer diameter, so that different surgical rod diameters may beused without the need for a bending robot to adjust to different outsidediameters of the respective coverings.

FIGS. 11A and 11B illustrate components of a bending robot 1100according to another alternative embodiment. The bending robot 1100 inthis embodiment includes a rod feeding subassembly 1104 including a rodfeeding actuator 1124, a brake subassembly 1108 with a brake actuator1146 having an integrated marking mechanism, and bending subassembly1110 having a bending actuator 1150 including a pair of roller bearings1154 configured to engage and bend the surgical rod 1106 withoutnotching or otherwise damaging the surgical rod 1106.

In this example, the rod feeding actuator 1124 is controlled via afeeding gear mechanism 1126, and the bending actuator 1150 is controlledvia a bending gear subassembly 1152. The brake actuator 1146 iscontrolled by a manual clamp mechanism 1180 in this embodiment. Anintegrated marking mechanism, e.g., a retractable marker, may markpoints on the rod which, once marked, dictate the shape of the rod asneeded to correct an injury, where the marked points indicate the pointsof the screws along the curve of the bend. This allows for additionalcontrol over the shape of the rod, and marking ensures that the surgeonis aware entirely of which screws the rod aligns with for a spinalfusion or other procedure. Alternatively, the surgical rod could bepre-marked, e.g., every five millimeters, with a corresponding number.By displaying these numbers on the screen of a monitor viewable by thesurgeon during the procedure, the surgeon can ensure proper positioningof the rods.

FIG. 12 is a flowchart of operations 1200 to operate a bending robot,according to some embodiments. The operations 1200 include sterilizing afirst housing including a rod feeding subassembly, a brake subassembly,and a bending subassembly (Block 1202), and removably coupling the firsthousing to a second housing including a motor configured to selectivelyoperate the rod feeding subassembly, the brake subassembly, and thebending subassembly (Block 1204). The operations 1200 further includeretaining a surgical rod in the rod feeding subassembly (Block 1206),causing a feeding actuator of the rod feeding subassembly to selectivelymove the surgical rod in a direction parallel to a longitudinal axis ofthe surgical rod (Block 1208), and causing the feeding actuator toselectively rotate the surgical rod about the longitudinal axis of thesurgical rod (Block 1210).

The operations 1200 further include receiving the surgical rod in thebrake feeding subassembly from the rod feeding subassembly (Block 1212),and causing a brake actuator of the brake subassembly to selectively fixa first portion of the surgical rod with respect to the brakesubassembly (Block 1214). The operations 1200 further include causing abending actuator of the bending subassembly to selectively rotate abouta first rotational axis perpendicular to the longitudinal axis of thesurgical rod, wherein rotating the bending actuator causes the bendingactuator to engage a second portion of the rod and bend the secondportion of the rod with respect to the first portion of the surgical rodso that the first portion and the second portion of the surgical roddefine a first bend angle. The operations 1200 further include causing ablade of the brake subassembly to selectively cut the surgical rod.

Additional operations may include data acquisition, which may occurprior to rod bending and after screws are properly placed via a camerasystem, which may send the data to the bending robot. Based on the data,the bending robot may perform the operations described above. In anotherembodiment, the data for bend points can be received through anacquisition camera and a probe that is tracked by the camera, where theprobe is touched on the head of each of a plurality of pedicle screwsafter they have been placed on the patient's spine. Those points can beused to generate a curve that can be modified and fine-tuned by thesurgeon, and that can be used to generate bend points, which can be usedby the bending robot to make appropriate bends in the surgical rod. Inanother example, an intra-operative robot used for screw placement canbe used to determine the coordinates of the pedicles and hence can beused to generate a bend curve. In some embodiments, preoperativeplanning software, such as Surgimap or GMAP, for example, can be used toconfigure the bend points, which can then be used by the bending robotto bend the surgical rod. Data from the camera may also be used toverify that the robot is operating correctly and/or within predeterminedtolerances, and may generate data to instruct the robot to correct forerrors in real time.

Further discussion of elements of bending robot 110 is provided belowwith respect to FIGS. 45-53 .

FIGS. 45, 46, and 47 illustrate additional details of a bendingsubassembly from a mechanical housing of a bending robot. As shown inFIGS. 45 and 46 , surgical rod 106 is fed into the bending subassembly(also referred to as a bend mechanism) using a rod feeding subassembly(also referred to as a feed carriage). Roller bearings 454 (alsoreferred to as bend rollers) surround respective bend posts 4501 whichpush the surgical rod 106 to create a precalculated bend in the surgicalrod. Roller bearings (bend rollers) 454 roll on respective bend posts4501 while pushing the surgical rod to reduce damage to the surface ofthe surgical rod while bending.

As shown, the roller bearings 454 and/or bend posts 4051 are attached toa plate of the bending actuator which includes a section of a spur gearreferred to as driven gear 4503. This larger driven gear 4503 iscontrolled by a smaller spur gear referred to as drive gear 4505. Thismechanism may provide sufficient mechanical advantage to match a torquevalue used/required to bend a metallic surgical rod. As shown in FIG. 47, drive gear 4505 is connected to bending actuator motor 472 via agearbox 4509 to provide the gear reduction used/required to bend thestrongest surgical rods used for spinal correction. Drive gear 4505 anddriven gear 4503 may be provided as elements of bending gearsubassembly.

FIGS. 48 and 49 illustrate additional details of a braking/cuttingsubassembly from a mechanical housing of a bending robot. The cut axismay use/require more than a thousand times gear reduction to provide atorque used/required to cut the strongest surgical rods used for spinalcorrection. As shown in FIGS. 48 and 49 , the cutter arm 4801 may beattached to a section of a bevel gear 4803. The section of the bevelgear 4803 may be compounded with a pinion bevel gear 4805, a big spurgear 4807, a small pinion spur gear 4809, and a right angle gearbox 4811to provide sufficient gear reduction in a mechanical coupling with motor4815 (which may be provided in a motor housing of the bending robot).The cutter arm rotates on a shear plane 4819 perpendicular to the topplate and cuts the rod through a shear mechanism. Rotation in a firstdirection may thus be provided to cut the rod, while rotation in asecond direction may be used to brake the rod (i.e., to hold the rod ina fixed position to prevent lengthwise and rotational movement) whilebending the rod as discussed below.

FIGS. 50 and 51 illustrate additional details of a rod feedingsubassembly from a mechanical housing of a bending robot. The rodfeeding subassembly may be used to feed and rotate a surgical rod 106.The feed/rotate axis may work using a differential drive assembly. Adifferential drive is achieved using a series of pulleys and a cable5003. The cable 5003 is wrapped around the pulleys and a drum 5005 asshown in FIGS. 50 and 51 . Rotating the drive pulleys 5001 a and 5001 bin the same direction rotates the drum 5005 in clockwise andcounter-clockwise directions respectively. Rotating the drive pulleys inopposite directions moves the carriage 5009 forward and backward. Anadvantage of such a mechanism may be that both the feed and rotation ofthe rod is achieved using just one mechanism. The drive pulleys may bedriven by respective motors 5011 a and 5011 b through respectivegearboxes. Motors 5011 a and 5011 b may be provided in a motor housing.The rod 106 is passed through the drum and is held using a collar 5015.The drum rotates on the carriage, and the collar is threaded into thedrum, holding the rod inside the drum.

The surgical rod 106 may need to be held firmly while bending it againstthe bend post and/or roller bearings. This may be achieved using a brakeattached to the cutter arm 4801. The cutter arm 4801 cuts the rod whenit rotates in the counter-clockwise direction and brakes the rod when itrotates in the clockwise direction. When the cutter arm 4801 rotates inthe clockwise direction, it rotates the brake actuator 5305 which inturn presses the brake arm 5307 on the rod 106 resulting in a brakingaction.

The brake may also be also used during the feed mechanism. In order tofeed the entire length of the rod the rod bender may works in thefollowing sequence:

-   -   1. Tighten the rod 106 onto the drum 5005 using the collar 5015.    -   2. Feed the rod 106 into the bend subassembly/mechanism for        bending operations until the carriage reaches the end of its        range of motion closest to the bending subassembly.    -   3. Brake (e.g., brake arm and brake actuator) holds the rod 106    -   4. Carriage 5009 slides back on the rod 106. This can be        achieved as the brake is much stronger than the holding collar.    -   5. Release the brake.    -   6. Repeat steps 2-5 as needed until rod bending operations are        complete.

Stated in other words, carriage 5009 may have a limited range of motion,and an effective range of motion may be increased by sliding thecarriage back on the rod (i.e., by braking the rod while sliding thecarriage back to its starting position most distant from the bendingsubassembly.

According to additional embodiments of inventive concepts, methods maybe provided to automatically bend rods using robotic processesintraoperatively, thereby saving time and effort for the surgeons,automating data acquisition, providing/maintaining sterility, and/ormaintaining/retaining strength of the rods.

Some embodiments of inventive concepts may also provide methods todetermine the springback in a rod of a known or unknown materialintraoperatively. These methods may allow the user to put any rod in therod bender without prior knowledge of the material/springback propertyof the rod.

Globus Rod Bender (GRB) systems disclosed herein may provide bending ofrods (also referred to as implants or rod implants) for surgical use inpatients. Prior techniques may require a surgeon to freehand transformthe rod implant(s). Freehand transforming can lead to inconsistencies inthe planned bend and/or create weak points in the rod through continuousnotching. GRB systems may use patient imaging from screw planning orintra-operative fluoroscopy to bend the implant using an autoclavablemechanical assembly, and the techniques used may allow the system tomaintain the sterility of the implant throughout the procedure frombending to placement.

Hardware for such GRB systems may be provided as discussed herein withrespect to FIGS. 13 and 14 , which show the Rod Bender System without adrape.

The sterilizable rod bender system of FIG. 13 may include a cart 1301with motor housing 122 (e.g., as shown in FIG. 3 ) on the cart 1301, andwith mechanical housing 121 (e.g., as shown in FIG. 3 ) on motor housing122. Motor housing 122 may also be referred to as an embedded motioncontrol system and may include motors, gearboxes and other electronics.Mechanical housing 121 may also be referred to as an autoclavable topassembly and may include mechanical systems that are compatible withhigh temperature autoclave sterilization. FIG. 13 shows the cart 1301,motor housing 122, and mechanical housing 121 without a drape for easeof illustration. FIG. 14 shows a drape 1401 sandwiched between themechanical housing 121 and the motor housing 122 and also covering upperportions of the cart 1301. Because the drape 1401 covers the motorhousing 122 (also referred to as motion control system), the motorhousing 122 is not visible in FIG. 14 .

The mechanical housing 121 (also referred to as the autoclavable topassembly) does not include any electrical or electronic components thatcould be damaged by conventional preoperative or intraoperativesterilization techniques, such as autoclaving, high-temperature steamsterilization, chemical sterilization, etc. Accordingly, the cart 1301and the motor housing 122 may be covered by the sterile drape 1401,while the sterile mechanical housing 121 is exposed. Cart 1301 mayinclude wheels 1302 a, 1302 b, and 1302 c to facilitate movement.

FIG. 14 provides illustration of the Globus Rod Bender system with thedrape 1401 installed over the cart 1301 and motor housing 122.

FIG. 15 illustrates an enlarged view of the rod bender system fullyassembled, without the drape 1401 engaged over the cart 1301 and motorhousing 122. FIG. 16 illustrates an enlarged view of the assembled rodbender system, with the drape 1401 engaged over the cart 1301 and overmotor housing 122.

FIG. 17 illustrates an exploded view of mechanical housing 121 providedas an autoclavable top assembly, drape 1401, motor housing 122, and cart1301 with an embedded motion control system included in motor housing122.

The engagement between the mechanical housing 121 (provided as anautoclavable top assembly) and the motor housing 122 with embeddedmotion control system may work as follows. The mechanical housing 121may have shafts (also referred to as transmission outputs) with rotaryseals. Rotary seals (e.g., radial shaft seals) may be used to sealrotary elements, such as a shaft or rotating bores against fluids, dust,dirt etc. The rotary seals create a barrier between surfaces whileallowing for rotary motion transfer. According to some embodiments,there may be four shafts (also referred to as transmission outputs)protruding from (or receiving elements on) the bottom of the mechanicalhousing 121 to facilitate bending (e.g., bending transmission output ofFIG. 3 ), braking and/or cutting (e.g., brake transmission output 170 ofFIG. 3 ), and feeding and/or rotating the rod (e.g., first and secondpulley transmission outputs 164 and 166 of FIG. 3 , also referred to asrod feeding/rotating transmission outputs). The bottom surface of themechanical housing 121 (also referred to as a top mechanical assembly)does not have any other holes and may be completely sealed as shown inin FIG. 21 .

A bottom surface of mechanical housing 121 engages with a top surface ofmotor housing 122 through the drape 1401 and a gasket 2201 on an outeredge of the motor housing 122 embedded in the cart 1301. As shown inFIG. 22 , the motor housing 121 embedded on the cart may have 4-shafts(also referred to as transmission inputs) 160, 162, 168, and 174 comingout from the top. According to some embodiments, the four shafts mayfacilitate bending (e.g., bending transmission input 174 of FIG. 3corresponding to bending transmission output 176), braking and/orcutting (e.g., brake transmission input 168 of FIG. 3 corresponding tobrake transmission output 170), and feeding and/or rotating the rod(e.g., first and second pulley transmission inputs 160 and 162 of FIG. 3, also referred to as rod feeding/rotating transmission inputs,corresponding to first and second pulley transmission outputs 164 and166). The shaft housings accommodate for parallel and angularmisalignment. The shafts coming out of the top of mechanical housing 121engage with the shaft housings in the bottom motor housing 122 tofacilitate motion transfer from the motors embedded in the motor housing122 to the mechanisms on the top mechanical assembly 121. The engagementmechanism can be chosen from a plurality of mechanisms includingsplines, gears, clutches, and other couplings.

The type of engagement between the top plate and bottom plate shafts maybe the same or different for all the axes, for example, based on theradial, axial and moment load. This engagement may provide the followingcharacteristics:

1. Self-centering;

2. Indexing accuracy; and/or

3. Capability to handle parallel, angular or combined misalignments.

FIGS. 18A, 18B, and 18C show examples of self-indexing couplings for therod bender between the mechanical housing 121 and the motor housing 122.According to some embodiments, a top coupling structure of FIG. 18A maybe provided for each of bending transmission output 176, braketransmission output 170, first pulley transmission output 164, andsecond pulley transmission output 166, and a bottom coupling structureof FIG. 18A may be provided for each of bending transmission input 174,brake transmission input 168, first pulley transmission input 160, andsecond pulley transmission input 162 (or vice versa). According to someother embodiments, a top coupling structure of FIG. 18B may be providedfor each of bending transmission output 176, brake transmission output170, first pulley transmission output 164, and second pulleytransmission output 166, and a bottom coupling structure of FIG. 18B maybe provided for each of bending transmission input 174, braketransmission input 168, first pulley transmission input 160, and secondpulley transmission input 162 (or vice versa). According to still otherembodiments, a top coupling structure of FIG. 18C may be provided foreach of bending transmission output 176, brake transmission output 170,first pulley transmission output 164, and second pulley transmissionoutput 166, and a bottom coupling structure of FIG. 18C may be providedfor each of bending transmission input 174, brake transmission input168, first pulley transmission input 160, and second pulley transmissioninput 162 (or vice versa). According to some other embodiments, adifferent coupling types may be used for different couplings (e.g., oneof the coupling types from FIG. 18A (flat head and corresponding slot),18B (pin and slot), or 18C (male and female splines) may be used toprovide couplings between first/second pulley transmission outputs andfirst and second pulley transmission inputs, and another of the couplingtypes from FIG. 18A, 18B, or 18C may be used to provide coupling betweenbending transmission output and bending transmission input and/orbetween brake transmission output and brake transmission input.

As can be seen in FIGS. 18A, 18B, and 18C, each of the couplings mayhave a capability of self-indexing. One way to achieve self-centering isto add a central projection to the center of top shafts (analogous to alive center in a lathe machine) as shown, for example, in FIG. 19 (whichillustrates a modification of the coupling of FIG. 18C), with acorresponding central depression of the opposing shafts. A centralprojection may be similarly added to couplings of FIGS. 18A and/or 18B.FIG. 19 shows an example how self-centering can be achieved using aspline shaft with a central projection. While the central projection isdiscussed with respect to the top shaft(s), the central projection maybe instead be provided on the bottom shaft with a corresponding centraldepression on the top shaft. The central projection, for example, may becone shaped, e.g., conical, paraboloidal, etc., and the correspondingdepression may have a shape matching that of the central projection.

Another method to engage the shafts of top plate and bottom plate isillustrated in FIG. 20 . As shown in FIG. 20 , a spring controlled pincan be placed on the top plate shaft and can be pressed against thebottom plate shaft. If the pin does not fall within the slot, the springwill be compressed. Once the motor starts rotating and the pin fallswithin the area of the slot, the spring is relaxed and both the shaftsstart rotating together in order to accomplish motion transfer from thebottom plate to the top plate. FIG. 18B shows an embodiment with twosuch pins that can be spring controlled as discussed above with respectto FIG. 20 .

FIG. 21 illustrates a bottom surface of the mechanical housing 121including bending transmission output 176, brake transmission output170, first pulley transmission output 164, and second pulleytransmission output 166.

FIG. 22 shows the cart 1301 with embedded motor housing 122 (Drape notshown) and with mechanical housing 121 pulled away. As shown in FIG. 22, bending transmission input 174, brake transmission input 168, firstpulley transmission input 160, and second pulley transmission input 162may extend from a top surface of motor housing 122.

Steps of engagement are discussed below with respect to FIG. 23 whichshows an exploded view of the components of the sterilizable rod bender.The top autoclavable mechanical housing 121 may include multiple rollerlatches 2301 as shown. The cart/motor mount has a movable engagementplate 2303 with a gasket 2305. Once the mechanical housing 121 is placedon the movable engagement plate 2303 and the roller latches 2301 (alsoreferred to as roller ratchets) are engaged, the gasket 2305 iscompressed and the mechanical housing 121 is sealed from the motorhousing 122. In alternative embodiments, the gasket 2305 may be providedon the top (non-moving) surface of motor housing 122 or the bottomsurface of mechanical housing 121. The gasket 2305 may provide atwo-fold functionality, that is: providing a seal between motor andmechanical housings 122 and 121 and/or providing that the drape issoftly held between a rigid surface and a flexible surface to providethat the drape does not tear with axial or shear loads. Then, themechanical housing 121 is pushed down which enables the shafts to beengaged with the shaft housings by pushing/puncturing through the drape.Given that the mechanical housing 121 first seals on the gasket and theshafts have rotary seals on them, the sterility may be preservedthroughout the assembly procedure.

In another embodiment of FIG. 24 , the mechanical housing 121 may have aflange 2401 with an internal gasket 2403 to facilitate a seal betweenthe mechanical housing 121 and the motor housing 122 after assembly. Thegasket 2403 can also serve as a tensioner to provide that the drape ispulled down along with the top plate prior to drape puncture and shaftengagement.

An alternative way to engage the shafts in the mechanical and motorhousings 121 and 122 is to place the motor housing on a linear rail andactuate it (up and down), for example, using a cam controlled with amanual lever arm 2503 as shown in FIG. 25 or a motor. The motor housing122 may be housed inside a stationary bottom box 2501 and may beactuated up and down, for example, using a lead screw, a cam mechanism,and/or a motor.

Operation for embodiments of FIG. 25 are discussed below.

The mechanical housing 121 is placed on the bottom box 2501 and latches2301 are closed. This provides that the mechanical housing 121 is sealedon the bottom box 2501.

The lever arm 2503 is rotated manually, which raises the motor housing122. The motor housing 122 may have the bottom shafts shaped analogousto die cutters to facilitate the cutting of the drape where the upperand lower shafts meet. This leads the shafts of the motor housing 122 topush through the drape and engage with the shafts in the mechanicalhousing 121. The motor housing 122 can be locked in this raisedposition. After the functionality of the rod bender has been achieved,the lever arm 2503 can disengage the motor housing 122 from themechanical housing 121.

An alternative to pushing/puncturing through the drape is to have apeelable drape 2601 where the shown portion (on top of motor housing122) in FIG. 26 can have a peel-able top to allow the shafts to engagethrough the peeled window. Fenestrated drapes can be used for thispurpose. Such a design may omit a movable engagement plate.

Some embodiments of inventive concepts may provide intraoperativeSpringback measurement. Bending rods intraoperatively may requireknowledge of spring back on the rod in order to bend the rod accuratelyto a predetermined position. Springback refers to the change in theangle of the rod after it has been released from the bending load. Itmight be cumbersome to input the material properties of each rod thatcan potentially be bent by the intraoperative rod bender.

As shown in FIG. 27 , the change in the angle of the rod while bendingcan lead to erroneous results during bending. In FIG. 27 , the dashedline indicates a desired bend position to which the rod bender may bendthe rod, and the solid line indicates an actual bend position (orspringback position) to which the rod returns after the bending force isreleased from the rod. To achieve the desired bend position, the rodbender may thus need to bend the rod past the desired bend position tocompensate for the springback.

Hence, methods of the following embodiments may provide ways todetermine the springback as a function of angle for a rod of anymaterial. FIG. 28 illustrates an example of a setup of the rod bendingsystem that may be used to determine springback characteristics (e.g.,by determining a springback equation) using a sacrificial rod 106′.

The sacrificial rod 106′ end can have a detachable reflective marker2811 (also referred to as a reflective sphere), which can be tracked inthree-dimensional (3D) space using intraoperative camera 114. The camera114 can be used to determine the position of the reflective marker 2811on the sacrificial rod 106′ with respect to a known reflective markerarray 2815 (also referred to as a tracking array) placed on the rodbending robot 100. The tracking array 2815 may include at least threereflective markers in a known orientation with respect to the bendingrobot to allow controller 102 to determine both a position andorientation of bending robot 100 and components thereof. The rod bendingrobot 100 may need to bend the end of the sacrificial rod 106′ to aknown angle and once the rod bending robot 100 releases the load onsacrificial the rod 106′, the controller 102 and camera 114 can monitorthe springback. This may need to occur for two data points (e.g., fortwo different bend angles) for the rod as discussed below with respectto FIG. 28 to determine springback characteristics of the rod over arange of bend angles (e.g., using a springback equation).

The springback equation for any material can be approximated to astraight line and hence the two different data points for springback onthe rod can be used to determine an equation for the material propertiesof the rod. The two data points can be obtained by choosing twodifferent bend angles at two different positions on the rod andcalculating the corresponding springback for each bend angle using thecamera 114. This equation can be used to bend the surgical rod 106accurately to the required position without having prior knowledgeregarding the material of the surgical rod. For example, a sacrificialrod may be provided with the surgical rod where the sacrificial andsurgical rods were manufactured together so that both have the samecharacteristics (e.g., the same diameter, the same material, the samespringback characteristics, etc.). Accordingly, springbackcharacteristics of the sacrificial and surgical rods will be the same,and a springback equation developed using the sacrificial rod can beused to accurately bend the surgical rod. The bending system 10 can thusbend the sacrificial rod to two different angles at two different pointsto determine the springback equation that is used to bend the surgicalrod.

According to some other embodiments, the spring back equation may bedetermined by monitoring motor current for the motor used to bend therod (e.g., bending actuator motor 172).

In such embodiments, the following operations may be performed.

A load may be applied on the sacrificial rod 106′ using the bend rotor(e.g., using bending actuator motor 172 to rotate bending actuator 150)and bend the sacrificial rod 106′ to the desired bend angle.

The bend rotor may be rotated back to its original position so as torelease the sacrificial rod 106′ from bend load.

The sacrificial rod 106′ will undergo a springback once the bend rotorstops contacting the sacrificial rod 106′.

Then, the bend rotor may be rotated back until it touches thesacrificial rod 106′. This can be determined by monitoring the motorcurrent as there will be a slight spike in motor current (e.g., currentto the bending actuator motor 172) when the bend rotor touches thesacrificial rod 106′. This is the position of the sacrificial rod 106′after the springback. The angular difference between the two pointsindicates the springback.

The above process may need to be repeated at a second position on thesacrificial rod 106′ for a different bend angle.

Using two springback data points, the springback equation for thesacrificial rod 106′ can be calculated and the surgical rod 106 can thenbe bent accurately using the springback equation determined using thesacrificial rod 106′ without requiring any prior knowledge of materialproperties of the surgical rod 106.

Because the sacrificial and surgical rods may be produced together in asame batch, lot, etc., the springback characteristics of the two may bethe substantially the same and/or identical. Accurate calibration of therod bender may thus be provided for each surgical rod based on actualcharacteristics of that rod. Accordingly, accuracy of bending may besubstantially unaffected by different characteristics of rods producedin different batches, lots, etc.

Intraoperative transformation point capture is discussed below accordingto some embodiments of inventive concepts.

The GRB software provides ways to shape a surgical implant device (e.g.,rod) based on captured transformation points. These points may becaptured using a probe including a probe handle that has an array whichcan be optically tracked using the camera 114 and a probe tip thatattaches to the handle and that fits into a screw or that is used tolocate where a rod will be placed. The handle includes its array whichis tracked and also an additional moveable stray marker as discussedbelow with respect to FIGS. 29A and 29B.

FIGS. 29A and 29B illustrate embodiments of rod bender capture probetip/handle assemblies according to some embodiments.

In FIG. 29A, the probe 2901 a includes a probe tip 2907 a and a trackingarray 2903 a with fixed markers 2905 a 1, 2905 a 2, 2905 a 3, and 2905 a4 and a moveable/stray marker 2911 a. The fixed markers are fixedrelative to each other and relative to the probe tip 2907 a so that aposition and orientation of probe tip 2907 a may be determined usingcamera 114 to determine positions of the fixed markers in threedimensional space and to thereby determine the position and orientationof the probe tip 2907 a in the three dimensional space. The moveablestray marker 2911 a may be used to signal that the probe tip is in theposition to be captured by the surgeon pressing the plunger so that thestray marker 2911 a moves relative to the fixed markers. Upon detectingmotion of stray marker 2911 a, controller 102 may determine the positionand orientation of probe tip 2907 a and this position/orientation may berecorded as a transformation point. The stray marker 2911 a can beactuated by a finger or thumb movement along a defined path in relationto the array 2903 a. When the stray marker 2911 a is moved (pressed) thesystem knows to capture the transformation point at the location of theprobe tip 2907 a. In FIG. 29B, the probe 2901 b includes a probe tip2907 b, a tracking array 2903 b (with fixed markers 2905 b 1, 2905 b 2,2905 b 3, and 2905 b 4), and a moveable/stray marker 2911 b. The fixedmarkers are fixed relative to each other and relative to the probe tip2907 b so that a position and orientation of probe tip 2907 b may bedetermined using camera 114 to determine positions of the fixed markersin three dimensional space and to thereby determine the position andorientation of the probe tip 2907 b in three dimensional space. Themoveable stray marker 2911 b may be used to signal that the probe tip isin the position to be captured by the surgeon pressing the plunger sothat the stray marker 2911 b moves relative to the fixed markers. Upondetecting motion of stray marker 2911 b, controller 102 may determinethe position and orientation of probe tip 2907 b as a transformationpoint. This stray marker 2911 b can be actuated by a finger or thumbmovement along a defined path in relation to the array 2903 b. When thestray marker 2917 b is moved (pressed) the system knows to capture thetransformation point at the location of the probe tip 2907 b. If thearray is able to rotate around the axis of the handle as shown in FIG.29B, the stray marker 2917 b will still be in the same position becauseit is in line with the axis of the handle. This embodiment of FIG. 29Bis shown in greater detail in FIGS. 30A and 30B. In FIG. 30A, theplunger is in an initial extended position, and in FIG. 30B, the plungerhas been depressed to indicated that the position and orientation of theprobe tip 2907 b should be captured as a transformation point.

It is also possible to have a different type of stray marker that clipsonto an array. Such a detachable stray marker may allow any probe orinstrument with an array to capture a specific tool location andorientation via the movement of a specific stray marker. FIGS. 31A and31B illustrate a stray marker 3111 attached to the center of a face ofarray 3103 including fixed markers 3105-1, 3105-2, 3105-3, and 3105-4.When the button 3117 is pressed, the probe tip location and orientationcan be captured.

The Probe tip may be made to interface with a screw or other rod holdingimplant, so that when the probe tip is engaged with a compatible screw aprecise location and orientation of the screw/head can be determined. Asshown in FIG. 32D, for example, a spinal implant screw 3251 may have athreads 3257 configured to secure the screw into bone and a tulip head3255 configured to receive a surgical rod 106. The tulip head 3255 mayhave a U-shaped recess 3259 configured to receive the surgical rod 106and a threaded recess configured to receive a locking cap 3261 to lockthe rod into place. Locking cap 3261, for example, may be threaded toscrew into an upper portion of the tulip head 3255 after placing therod.

As shown in FIG. 32A, the probe tip 3207 a may be paddle shaped with acylindrical center 3208 a which interfaces with the center of thescrew's tulip head (before placement of the rod and locking cap). Theprobe geometry of FIG. 32A may allow it to be used to manipulate thetulip head 3255 to better represent the direction which the rod would befacing. Because the paddle portion of probe tip 3207 a aligns with theU-shaped recess of the tulip head and the cylindrical portion alignswith the opening for the locking cap, when properly placed, the probetip 3207 a will align with both the center of the tulip head and adirection of the rod through the tulip head allowing determination ofboth the location and alignment of the U-shaped opening.

As shown in FIG. 32B, a side loading probe 3207 b may interface withdifferent connectors or screws that cannot be accessed from the top. Thehook 3210 b of the probe would represent the rod and allow the captureof a specific trajectory without requiring top access. FIG. 32C showsthe side loading probe 3207 b interfacing with a connector 3221 c (withhook 3210 b inside connector 3221 c).

Software and/or control components of the rod bending system 10 arediscussed below according to some embodiments of inventive concepts.

Software and/or control components (e.g., controller 102) of someembodiments of inventive concepts may provide a way to overlay capturedtransforms over patient images using display 118. Utilizing thetransformation points, the controller/software may control the bendingrobot 100 to shape an implant for operational use. Additionally, priorto shaping the implant, the user (e.g., the surgeon) may also labeltransformation points to correspond to the patient's anatomy where bendsmay be needed (e.g., the S1-S4 vertebrae), a feature illustrated in FIG.33 . As shown in FIG. 33 , four transformation points are illustrated inthe upper and lower views taken in orthogonal planes/views (e.g., theSagittal and Coronal planes), and these transformation points areidentified as the first, second, third, and fourth sacral vertebrae(i.e., S1, S2, S3, and S4). These transformation points may be opticallydetermined using camera 114 to determine probe tip placements inrespective screws or other implants, for example, as discussed abovewith respect to FIGS. 29A, 29B, 30A, 30B, 31A, 31B, 32A, 32B, and 32C.Because the transformation points may be determined based on theexisting spinal alignment, the user (e.g., surgeon) may adjust thetransformation points on display 118 before initiating rod bending asindicated by the circle and arrow at the left most transformation pointin each of the views of FIG. 33 .

Controller/software operations to acquire transformation points mayinclude pre-operative and/or intraoperative workflows, for example, asdiscussed below.

Intra-Operative acquisition of transformation points is discussed below.

To track rod attachment point acquisition, the controller/software mayhave the ability to automatically capture rod attachment points atrespective screws (after screw placement), including the screw headorientation and position. Probes used to capture such rod attachmentpoints are discussed above. Using the controller/software, the user(e.g., surgeon) can then send this captured information to the rodbender (e.g., rod bending robot) to shape the rod implant for clinicaluse.

The controller/software can provide a way to optically captureattachment points using camera 114, for example, based on a position ofa probe in camera space and/or a position of a probe with respect to apatient fixation tracking array. The controller/software may track probeposition based on information from camera 114 and capture a currentposition/orientation of the probe tip responsive to stray movement(e.g., using a movable stray marker/reflector as discussed above withrespect to FIGS. 29A, 29B, 30A, 30B, 31A and/or 31B) relative to thecamera 114 or responsive to user interface (UI) action (e.g., via atouch sensitive portion of display 118, a physical button, a pedal,etc.). The user (e.g., surgeon) is also able to make adjustments incardinal directions of transformation points before bending/shaping theimplant, as shown in FIG. 34 . In FIG. 34 , initial transformationpoints have been input (e.g., optically captured) for screws in thefirst, second, third, and fourth sacral vertebrae (i.e., S1, S2, S3, andS4), with the transformation point for the first sacral vertebrae S1selected for adjustment as indicated by highlighting “S1” on the rightof the screen and by displaying a circle around the S1 transformationpoint in both of the sagittal and coronal views. In this configuration,the user (e.g., surgeon) can adjust the location of the S1transformation point in the sagittal view and/or coronal view to affectmovement of the S1 transformation point in three dimensions. Any of theother transformation points (e.g., the S2, S3, and/or S4 transformationpoints) may be selected and adjusted in a similar manner. Adjustment maybe performed by controller/software responsive to user input throughtouch sensitive portions of display 118, and/or responsive to user inputthrough a separate user input interface (e.g., a mouse, joystick, trackball, keypad, etc.). For example, the user may touch the respectivelabel (e.g., “S1”, “S2”, “S3”, or “S4”) on the right side of display 118to select the respective transformation point, or the user may touch atransformation point in either the sagittal view or coronal view toselect the transformation point. Once a transformation point isselected, the user may touch and drag the selected transformation pointin the sagittal view to adjust a position of the transformation point inthe sagittal plane, and/or the user may touch and drag the selectedtransformation point in the coronal view to adjust a position of thetransformation point in the coronal view.

According to some embodiments, fluoroscopy can be used for attachmentpoint acquisition (also referred to as capture). The GRB can usefluoroscopic images to construct a bend plan for the rodintraoperatively. The user (e.g., surgeon) may capture fluoroscopyimages of the patient. The controller/software will automatically locateand label attachment points for the rod based on screw placement asshown in FIG. 35 . The user (e.g., surgeon) will be able to view thesepoints in the sagittal and coronal views as shown in FIG. 35 and makeadjustments as useful/necessary to obtain the desired bend plan for therod.

Once the user (e.g., surgeon) reviews and accepts the bend plan, the GRBwill shape the rod implant for surgical use.

Shaping the rod implant based on screw location in fluoroscopy isillustrated in FIG. 35 . In FIG. 35 , display 118 provides twoorthogonal fluoroscopic images with 5 spinal screws identified forplacement of surgical rod 106, and the 5 screws are identified as screwsfor the first, second, third, fourth, and fifth sacral vertebrae (i.e.,S1, S2, S3, S4, and S5). The controller/software may automaticallyidentify the five illustrated initial transformation points for the rodbased on locations of the respective screws and create an initial bendplan for the rod based on the initial transformation points. The user(e.g., surgeon) may then select a transformation point on the display118 for adjustment (e.g., by selecting/touching the respective label onthe right of display 118, or by selecting/touching the respectivetransformation point in the sagittal or coronal view). In FIG. 35 , thetransformation point corresponding the S1 vertebrae is selected foradjustment as indicated by the box highlighting the label “S1” on theright side of display 118 and the circle (with arrows) surrounding therespective transformation point. The user may select and adjust one ormore of the transformation points to provide a modified bend plan forthe rod before initiating actual rod bending. Selection and/oradjustment may be provided as discussed above with respect to FIG. 34 .

Pre-Operative operations are discussed below according to someembodiments of inventive concepts.

According to some embodiments, a screw plan may be used to generate abend plan for a rod. The controller/software may allow the surgeon toplan a shape (also referred to as a bend plan) for the surgical rodimplant based on attachment point placement created using theExcelsiusGPS system. In such embodiments, pre-operative imaging (e.g.,CAT scan imaging, Mill imaging, fluoroscopic imaging, etc.) may be usedto provide images of the patient's anatomy (e.g., spine) in different(e.g., orthogonal) planes (e.g., sagittal and coronal planes) on display118. Controller/software may then accept user input (e.g., using touchsensitive portions of display 118) to place virtual screws for theprocedure on the display to provide the screw plan for the procedure.After placement of the virtual screw implants, the controller/softwarecan automatically identify rod placement points for each virtual screwto provide initial transformation points for an initial rod bend plan,and the user can modify one or more of the initial transformation pointsto provide modified transformation points used to generate a modifiedbend plan for the rod. Once the user approves the bend plan, the usercan send the bend plan (e.g., surgical shape) to the rod bender andshape the rod implant to fixate to attachment points of the screws.

Generation of a rod bend plan based on pre-operative virtual screwplacement may be similar to intra-operative bend planning discussedabove with respect to FIGS. 33, 34 , and 35 that are based on actualscrew placement. With both intra-operative and pre-operative bendplanning, initial transformation points for an initial bend plan for therod may be generated based on respective (real or virtual) screwplacements, and the user may adjust one or more of the initialtransformation points to generate the final bend plan for the rod. Theimaging used for virtual screw placements may be similar to that ofFIGS. 33, 34 , and/or 35 except that the images of the virtual screwsare added by the controller/software based on user input (as opposed tobeing included as a part of the original imaging.

If the surgeon does not use the GPS to insert the actual screw implants,the controller/software can still shape the surgical implant based onvirtual/real attachment/screw point placement with other means, providedthe plan is produced in proprietary format. After placing thereal/virtual screw implants, the user can send the bend plan to the GRB,which will then shape the rod to allow fixation to the screw attachmentpoints.

Merging of plans between pre-operative and intraoperative plans may alsobe provided according to some embodiments of inventive concepts. Thecontroller/software may provide a way to combine two or more plans toform a merged plan. The user will be able to assign weights to bothpredicate plans that are used to calculate the merged bend plan,depending on the accuracy of each of the desired bend locations, asshown, for example, in FIG. 36 .

Whether using placement of actual or virtual screws to generate a bendplan for a surgical rod, controller 102 may generate the bend plan toboth: 1) fit points on the rod to respective transformation points(corresponding to respective attachment implants, e.g., screws); and 2)orient a trajectory of the rod at each transformation point to match atrajectory of the respective attachment implant (e.g., atrajectory/direction of a tulip head of the respective screw).Accordingly, the bend plan for the rod may consider both the positionsof the attachment implants (e.g., screws) and the orientations of theattachment implants (e.g., orientations of tulip heads of the screws).

According to some embodiments of inventive concepts, software-basedimplant shaping verification may be provided.

After shaping the implant, the controller/software may provideverification that the implant is properly shaped using one or moreapproaches discussed below.

Tip verification may be provided as discussed below after completion ofrod bending but before cutting the rod.

Using a tracked array 2815 on a base of the system, the user may be ableto touch a tip of a tracked instrument to the tip/end of the rod implantafter completion of bending but before cutting the rod. A numericalestimate of the accuracy of the bend may be provided on display 118 tothe user for shape verification. Based on the intended bend plan, thecontroller/software can determine a planned/calculated position of thetip/end of the rod after completion of all bends, and theplanned/calculated position of the tip/end of the rod can be comparedwith the actual position of the tip/end to generate the numericalestimate of accuracy of the rod shape. A single data point may thus beused to provide the numerical estimate of the overall accuracy of therod shape.

Shape verification may be provided as discussed below after completionof rod bending but before cutting the rod.

Using a tracked array 2815 on the base of system, the user may be ableto run a circular probe over the length of the implant and sample probelocations corresponding to respective rod locations to generate anumerical estimate of an accuracy of the rod shape after completion ofrod bending but before cutting the rod. Based on the intended bend plan,the controller/software can determine planned/calculated positions alongthe length of the bend plan for the rod, and these planned/calculatedpositions may be compared with the actual sampled probe locations atcorresponding positions along the length of the actual bent rod togenerate the numerical estimate of the accuracy of the rod shape. Aplurality of data points may thus be used to provide the numericalestimate of the overall accuracy of the rod shape.

Tool verification may be provided as discussed below after completion ofrod bending and after cutting the rod.

Using two tracked instruments/probes, the user may touch both ends ofthe implant to verify shape accuracy using calculations based on wherethe tips of the rod implant are in relation to the center of the rodimplant after completion of bending and before/after cutting. Based onthe intended bend plan, the controller/software can determine aplanned/calculated distance between the two tips/ends of the rod, and anactual distance between the two tips/ends of the actual bent rod can bedetermined based on an optical determination of the actual tips/ends ofthe bent rod using camera 114 and the tracked probes.

Placement of the rod implant is discussed below according to someembodiments of inventive concepts.

After checking/ensuring accuracy of the rod implant shape/properties(e.g., bends, length, etc.), the user may cut the rod implant and thenplace the implant into the tulips of the screw heads and secure the rodin each screw using a respective locking cap.

After the automatic rod bender has bent the rod, it may be difficult forthe user (e.g., surgeon) to know the proper orientation of the rod withrespect to the spine. Even after the user (e.g., surgeon) is able todetermine the proper orientation of the rod, the user (e.g., surgeon)may need to fix an end of the rod to the first/last screw toprovide/ensure that the rod does not slide while fixing it to theother/remaining screws. The fixing of the rod to the last/first screwmay also help to provide/ensure that the rod falls accurately where itneeds to be without the rod sliding on the screws.

The following approaches may help the user (e.g., surgeon) to orient therod 106 with respect to the spine and/or to fix the rod 106 on thefirst/last screw.

According to some embodiments, an extra bend 3801 may be added to therod 106 before cutting as shown in FIG. 37 .

The extra bend 3701 can be added to the end of the already bent rod 106using the automatic rod bender. The extra bend 3701 can be used both toassist the user (e.g., surgeon) to orient the rod and/or toreduce/prevent sliding of the rod during/after the procedure as shown,for example, in FIG. 37 . As shown in FIG. 37 , the extra bend 3701 maystop the bent rod 106 from sliding to the left through the tulip head3703 of screw 3705 while securing the rod to other screws (not shown).The extra bend can also assist in proper placement of the rod relativeto the first/last screw 3805 by providing a “stop” against the tuliphead 3703 when the rod is properly positioned. In addition, a directionof the extra bend 3701 can be used to indicate a proper rotation of therod relative to screw 3705. For example, the portion of the rod betweenthe extra bend 3701 and rod end 3711 may be configured to lay horizontal(or vertical) when the rod is in a proper rotational position. Byproviding that portions of the rod between the extra bend 3701 and theend of the rod 3711 are configured to extend in a direction that isorthogonal with respect to sides of the U-shaped opening in the tuliphead, the bend may act as a “stop” with respect to rod 106 sliding tothe left in FIG. 37 .

According to some embodiments, markings 3821 on the rod 106 may be usedto orient the rod 106 as shown in FIG. 38 . Many spinal rods may comewith a distinct dotted or solid midline marking 3821, as illustrated inFIG. 38 . The following operations can be followed to use the midline3821 as an orientation marker.

According to some embodiments, the rod 106 may be inserted into the rodbender (e.g., into rod feeding subassembly 104) in a way that themidline 3821 faces up. There can also be a central line on the rodbender to help the user match the rod to this line. This may be referredto as the home position of the rod 106 prior to initiating bending.

According to some embodiments, the rod bender controller/software mayknow precisely the total rotation the rod needs to go through to achievethe 3D bending.

At the start of bending operations the rod bender can rotate the rod tosuch a position such that after the rod has been completely bent by therod bender, the midline faces up when oriented as intended for fixationto the patient.

According to some embodiments, a biocompatible cap 3901 may be providedat the end of the rod 106 as shown in FIG. 39 .

A biocompatible cap 3901 as illustrated in FIG. 39 can be placed at theend of the rod 106 to help the user (e.g., surgeon) determine theorientation of the rod 106 with respect to the spine after the rod 106is bent and at the same time reduce/prevent sliding of the rod on thepolyaxial screw head. The cap may need to be placed on the front end ofthe rod 106 (i.e., the end that is first fed into the rod feedingsubassembly 104 and the bending subassembly 110) as the other end of therod is cut. The cap can be threaded or pressfit to the end of the rod.After the rod has been fixed to the spine, the cap can be removed. Asmentioned with respect to embodiments discussed above, thecontroller/software may know exactly the amount of rotation that the rodhas to go through to facilitate 3D (three dimensional) bending. Afterthe rod is inserted into the rod bender (but before initiating bending),the cap can be placed in such a way that a standoff feature 3903 on thecap faces up. This may indicate a home position. Now the rod bender canrotate the rod to a position so that after the rod is bent completely,the standoff feature 3903 faces up when properly oriented for fixationto the patient. In this way a desired orientation of the rod may beindicated to the user (e.g., surgeon) when placing/fixing the rod to thespinal screws.

According to some embodiments of inventive concepts, sterility of themechanical housing 121 (also referred to as a top assembly) may bemaintained throughout rod bending operations. In particular, themechanical housing 121 may be compatible with autoclave sterilization,and a sterile drape can be used to isolate the motor housing 122 fromthe sterile surgical environment while providing mechanical couplingbetween the mechanical and motor housings. During rod bendingoperations, the rod is thus in contact with components of the sterilemechanical housing 121 while the rod is isolated from the motor housing122 which may be incompatible with autoclave sterilization.

According to some embodiments of inventive concepts, placement of therod bender system on a cart may improve mobility of the system.

According to some embodiments of inventive concepts, an automaticspringback equation calculation can be performed on a sacrificial rod(matched to the actual rod implant) to enable the rod bender to bendrods of any material without any prior data regarding the rod'smaterial/springback properties.

According to some embodiments of inventive concepts, a rod bendingsystem may be able to seamlessly capture and shape surgical rod implantsbased on multiple different acquisition methods. The open platformdesign may allow a user to select the implant system that best suits thepatient.

According to some embodiments of inventive concepts, a rod bendingsystem may also be able to rapidly shape the rod implant in under twominutes, reducing an amount of time the patient is under anesthesia aswell as reducing stress on the patient when inserting the rod implant.

According to some embodiments of inventive concepts, a rod bendingsystem may use patient specific transformation points (including livetransformation points generated based on fluoroscopy) to captureattachment points. This may assist in generating a best-fit shape forthe attachment/bend plan.

FIG. 40 is a block diagram illustrating elements of controller 102 ofrod bending system 10. As shown, controller 102 may include processor4007 (also referred to as a processor circuit or processor circuitry)coupled with input interface 4001 (also referred to as an inputinterface circuit or input interface circuitry), output interface 4003(also referred to as an output interface circuit or output interfacecircuitry), control interface 4005 (also referred to as a controlinterface circuit or control interface circuitry), and memory 4009 (alsoreferred to as a memory circuit or memory circuitry). Memory 4009 mayinclude computer readable program code that when executed by processor4007 causes processor 4007 to perform operations according toembodiments disclosed herein. According to other embodiments, processor4007 may be defined to include memory so that a separate memory circuitis not required.

As discussed herein, operations of controlling a rod bending systemaccording to some embodiments of the present disclosure may be performedby controller 102 including processor 4007, input interface 4001, outputinterface 4003, and/or control interface 4005. For example, processor4007 may receive user input through input interface 4001, and such userinput may include user input received through a touch sensitive portionof display 118 and/or through other user input such as a keypad(s),joystick(s), track ball(s), mouse(s), etc. Processor 4007 may alsoreceive optical input information from camera 114 and/or feedbackinformation from bending robot 100 through input interface 5001.Processor 4007 may provide output through output interface 4003, andsuch output may include information to render graphic/visual informationon display 118. Processor 4007 may provide robotic controlinformation/instruction through control interface 4005 to bending robot100, and the robotic control instruction may be used, for example, tocontrol operation of rod feeding subassembly 106, brake subassembly 108,and/or bending subassembly 110.

FIG. 41 illustrates operations of controller 102 according to someembodiments of inventive concepts.

At block 4101, processor 4007 may provide a set of transformation pointscorresponding to respective attachment implants (e.g., screws). Thetransformation points of the set may be provided, for example, based onat least one of: optically capturing locations of attachment implantsaffixed to a patient using camera 114 (e.g., using a tracked probe topoint to attachment implants); locations of actual attachment implantsin a medical image; and/or locations of virtual attachment implants in amedical image.

At block 4105, processor 4007 may generate a bend plan for the surgicalrod based on the set of transformation points. The bend plan, forexample, may define a plurality of bend angles at respective bendpositions along the surgical rod and corresponding rotational positions.

At block 4109, processor 4007 may generate an image output (providedthrough output interface 4003 to display 118) to render the set oftransformation points and the bend plan on display 118 as discussedabove, for example, with respect to FIGS. 33, 34, 35, and 36 . As shownin embodiments of FIGS. 33, 34, 35, and 36 , the image output may begenerated to render the set of transformation points and the bend planin a first plane (e.g., the Sagittal plane) on a first portion of thedisplay 118 and to render the set of transformation points and the bendplan in a second plane (e.g., the coronal plane) on a second portion ofthe display 118, with the first and second planes being different (e.g.,orthogonal). As shown in embodiments of FIG. 35 , the image output maybe generated to render the set of transformation points and the bendplan together with a medical image (e.g., a computed tomography CT scanimage, an magnetic resonance imaging Mill image, and/or a fluoroscopyimage) on the display 118. As further shown in FIG. 35 , the imageoutput may be generated to render the set of transformation points andthe bend plan on the display 118 with a medical image includingreal/virtual attachment implants (e.g., screws).

At block 4111, processor 4007 may proceed with rod bending responsive toreceiving user input (through input interface 4001) to proceed. Forexample, the user (e.g., surgeon) may adjust one or more of thetransformation points on the display 118 to adjust the bend plan beforeactually bending the surgical rod.

At block 4131, a sacrificial rod 106′ may be used to determine aspringback characteristic for the surgical rod 106 before bending thesurgical rod as discussed above, for example, with respect to FIGS. 27and 28 . Responsive to user input to accept/use the bend plan at block4111, processor 4007 may generate image output (provided through outputinterface 4003 to display 118) to render a prompt on display 118 to loadsacrificial rod 106′ into bending robot 100, and once the sacrificialrod has been loaded, processor 4007 may proceed with determining thespringback characteristic for the surgical rod using the sacrificial rod106′. Processor 4007 may proceed with springback characteristicdetermination responsive to determining loading of the sacrificial rodbased on feedback (received through input interface 4001) from bendingrobot 100 and/or camera 118 and/or based on user input (e.g., receivedthrough a touch sensitive portion of display 118 and input interface4001) that loading is complete.

As discussed above, the springback characteristic may be determinedbased on a detected springback of the sacrificial rod 106′ at twodifferent bend angles. Accordingly, processor 4007 may generateinstruction (provided through control interface 4005 to bending robot100) to bend the sacrificial rod 106′ at a first test position to afirst test bend angle, and responsive to this instruction, rod feedingsubassembly 104 of bending robot 100 may feed the sacrificial rod 106′to the first test position, brake subassembly 108 may lock thesacrificial rod 106′ in the first test position, and bending subassembly110 may bend the sacrificial rod to the first test bend angle. Processor4007 may then determine a first springback from the first test bendangle, for example, based on optical feedback received through camera114 and/or based on detecting a point at which the bending subassemblyreengages the sacrificial rod after release. Processor 4007 may thengenerate instruction (provided through control interface 4005 to bendingrobot 100) to bend the sacrificial rod 106′ at a second test position toa second test bend angle, and responsive to this instruction, rodfeeding subassembly 104 of bending robot 100 may feed the sacrificialrod 106′ to the second test position, brake subassembly 108 may lock thesacrificial rod 106′ in the second test position, and bendingsubassembly 110 may bend the sacrificial rod 106′ to the second testbend angle. Processor 4007 may then determine a second springback fromthe second test bend angle, for example, based on optical feedbackreceived through camera 114 and/or based on detecting a point at whichthe bending subassembly reengages the sacrificial rod 106′ afterrelease. Processor 4007 may then determine the springback characteristicfor the surgical rod based on the first springback from the first testbend angle from the sacrificial rod 106′ and the second springback fromthe second test bend angle for the sacrificial rod 106′. Whiledetermination of the springback characteristic is shown after generatingthe bend plan, the springback characteristic may be determined at anytime prior to rod bending.

Once the springback characteristic for the surgical rod 106 has beendetermined, processor 4007 may generate a prompt on display 118 to loadthe surgical rod 106 into bending robot 100, and once the surgical rodhas been loaded, processor 4007 may proceed with bending operations ofblock 4135 as discussed below. Processor 4007 may proceed with bendingoperations responsive to determining loading of the surgical rod basedon feedback (received through input interface 4001) from bending robot100 and/or camera 118 and/or based on user input (e.g., received througha touch sensitive portion of display 118 and input interface 4001) thatloading is complete.

At block 4135, processor 4007 may generate instruction to bend thesurgical rod based on the bend plan and based on the springbackcharacteristic for the surgical rod in block 4131. Accordingly,instruction for each bend may be provided so that bending subassembly110 bends the surgical rod (based on the springback characteristic) pastthe desired bend angle so that that the desired bend angle is achievedafter springback. Rod bending operations of block 4135 are illustratedin greater detail in FIG. 44 .

At block 4401, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to feed the surgical rod toa first bend position of the plurality of bend positions. Responsive tothis instruction, rod feeding subassembly 104 may feed the surgical rodto the first bend position.

At block 4405, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to rotate the surgical rodto a first rotational position. Responsive to this instruction, rodfeeding subassembly 104 may rotate the surgical rod to the firstrotational position.

At block 4409, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to bend the surgical rod toa first bend angle of the plurality of bend angles while the surgicalrod is maintained at the first bend position and the first rotationalposition. Responsive to this instruction, brake subassembly 108 may lockthe surgical rod in the first bend position and the first rotationalposition while bending subassembly 110 bends the surgical rod to thefirst bend angle (e.g., bending the surgical rod past the first bendangle in accordance with the springback characteristic so that the firstbend angle is achieved after completion of the operation).

At block 4411, processor 4007 may generate (4401) instruction (providedthrough control interface 4005 to bending robot 100) to feed thesurgical rod to a next bend position of the plurality of bend positions.Responsive to this instruction, rod feeding subassembly 104 may feed thesurgical rod to the next bend position.

At block 4415, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to rotate the surgical rodto a next rotational position. Responsive to this instruction, rodfeeding subassembly 104 may rotate the surgical rod to the nextrotational position.

At block 4419, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to bend the surgical rod toa next bend angle of the plurality of bend angles while the surgical rodis maintained at the next bend position and the next rotationalposition. Responsive to this instruction, brake subassembly 108 may lockthe surgical rod in the next bend position and the next rotationalposition while bending subassembly 110 bends the surgical rod to thenext bend angle (e.g., bending the surgical rod past the next bend anglein accordance with the springback characteristic so that the next bendangle is achieved after completion of the operation).

Operations of blocks 4411, 4415, and 4419 may be repeated for each bendof the bend plan provided to fit the surgical rod to the attachmentimplants (e.g., screws) corresponding to the transformation points,until rod bending is complete at block 4421.

According to some embodiments, operations 4431, 4435, and 4439 may beperformed to provide a final bend (also referred to as an extra bend)configured to provide a stop with respect to an attachment implant(e.g., screw) corresponding to the last of the transformation points.Such bends are discussed above with respect to FIG. 37 .

At block 4431, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to feed the surgical rod toa final bend position after the last of the transformation points forthe bend plan. Responsive to this instruction, rod feeding subassembly104 may feed the surgical rod to the final bend position.

At block 4435, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to rotate the surgical rodto a final rotational position. Responsive to this instruction, rodfeeding subassembly 104 may rotate the surgical rod to the finalrotational position.

At block 4439, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to bend the surgical rod tothe final bend angle while the surgical rod is maintained at the finalbend position and the final rotational position. Responsive to thisinstruction, brake subassembly 108 may lock the surgical rod in thefinal bend position and the final rotational position while bendingsubassembly 110 bends the surgical rod to the final bend angle. As notedabove, the final bend angle may be configured to provide a stop withrespect to the attachment implant corresponding to the last of thetransformation points.

According to some embodiments, instructions from different blocks ofFIG. 44 may be provided separately to bending robot 100 as eachoperation is performed, or instructions from different blocks of FIG. 44may be provided to bending robot 100 together so that bending robot mayperform instructions from a group of blocks with some autonomy.According to some embodiments, controller 102 may be defined to includecontrol elements at bending robot 100, and according to some otherembodiments, bending robot 100 may include a separate controller thatreceived instruction from controller 102 to control bending operationsat bending robot 100 based on instruction from controller 102.

At block 4139 of FIG. 41 , processor 4007 may verify a shape of thesurgical rod based on the bend plan and based on optical feedbackreceived through camera 114 after completion of bending the surgical rodat each of the bend positions. For example, the optical feedback may beused to identify a location of at least one point of the rod in spacebased on a position of a probe tracked using camera 118. Suchverification may be performed, for example, as discussed above withrespect to implant shaping verification (e.g., tip verification, shapeverification, tool verification, etc.). Processor 4007, for example, maydetermine a numerical verification score that is provided on display118, and/or may provide a pass/fail indication on display 118.

At block 4141, processor 4007 may generate instruction (provided throughcontrol interface 4005 to bending robot 100) to cut the surgical rodafter completion of bending the surgical rod at each of the bendpositions. Responsive to this instruction, bending robot 100 may cut thesurgical rod to remove excess portions there so that the surgical rodcan be secured to the attachment implants (screws). While instruction tocut the surgical rod may follow instruction to verify rod shapeaccording to some embodiments, according to some other embodiments, theorder may be reversed.

FIG. 42 illustrates operations of controller 102 according to some otherembodiments of inventive concepts.

At block 4201, processor 4007 may provide an initial set oftransformation points corresponding to respective attachment implants(e.g., screws). The transformation points of the initial set may beprovided, for example, based on at least one of: optically capturinglocations of attachment implants affixed to a patient using camera 114(e.g., using a tracked probe to point to attachment implants); locationsof actual attachment implants in a medical image; and/or locations ofvirtual attachment implants in a medical image.

At block 4205, processor 4007 may generate an initial bend plan for thesurgical rod based on the initial set of transformation points. Theinitial bend plan, for example, may define a plurality of bend angles atrespective bend positions along the surgical rod and correspondingrotational positions.

At block 4209, processor 4007 may generate an initial image output(provided through output interface 4003 to display 118) to render theinitial set of transformation points and the initial bend plan ondisplay 118, as discussed above, for example, with respect to FIGS. 33,34, and 35 . As shown in embodiments of FIGS. 33, 34, and 35 , theinitial image output may be generated to render the initial set ofinitial transformation points and the initial bend plan in a first plane(e.g., the Sagittal plane) on a first portion of the display 118 and torender the initial set of transformation points and the initial bendplan in a second plane (e.g., the coronal plane) on a second portion ofthe display 118, with the first and second planes being different (e.g.,orthogonal). As shown in embodiments of FIG. 35 , the initial imageoutput may be generated to render the initial set of transformationpoints and the initial bend plan together with a medical image (e.g., acomputed tomography CT scan image, an magnetic resonance imaging Millimage, and/or a fluoroscopy image) on the display 118. As further shownin FIG. 35 , the initial image output may be generated to render theinitial set of transformation points and the bend plan on the display118 with a medical image including real/virtual attachment implants(e.g., screws).

After providing the initial image output on display 118, processor 4007may accept user input to adjust one or more transformation points of theinitial set as discussed below. At blocks 4211 and 4215, processor 4007may accept user input to adjust one of the transformation points. Asdiscussed above with respect to FIGS. 33, 34, and 35 , for example, oneof the transformation points (e.g., transformation point S1, as shown)may be selected (e.g., via touch sensitive portions of display 118 orother user input) and moved/dragged (e.g., via touch sensitive portionsof display 118 or other user input). Responsive to user input to adjustthe transformation point (e.g., transformation point S1, as shown),processor 4007 may adjust the transformation point to provide anadjusted set of transformation points at block 4219.

At block 4221, processor 4007 may generate an adjusted bend plan for thesurgical rod based on the adjusted set of transformation points. Theadjusted bend plan may thus define an adjusted plurality of bend anglesat respective adjusted bend positions along the surgical rod andcorresponding adjusted rotational positions determined based on theadjusted transformation point.

At block 4225, processor 4007 may generate an adjusted image output(provided through output interface 4003 to display 118) to render theadjusted set transformation points and the adjusted bend plan on display118. the adjusted image output may be generated to render the adjustedset of transformation points and the adjusted bend plan in a first plane(e.g., the Sagittal plane) on a first portion of the display 118 and torender the adjusted set of transformation points and the adjusted bendplan in a second plane (e.g., the coronal plane) on a second portion ofthe display 118, with the first and second planes being different (e.g.,orthogonal). Moreover, the adjusted image output may be generated torender the adjusted set of transformation points and the adjusted bendplan together with a medical image (e.g., a computed tomography CT scanimage, an magnetic resonance imaging MRI image, and/or a fluoroscopyimage) on the display 118. In addition, the adjusted image output may begenerated to render the adjusted set of transformation points and theadjusted bend plan on the display 118 with a medical image includingreal/virtual attachment implants (e.g., screws).

Operations of blocks 4211, 4215, 4219, 4221, 4225, and 4229 may berepeated any number of times to adjust any number of the transformationpoints any number of times until user input is received (e.g., through atouch sensitive portion of display 118 or other user input device) toaccept the bend plan at block 4229. If no user input is provided atblock 4221, the initial bend plan may be accepted at block 4229 toprovide an accepted bend plan. If one or more transformation points areadjusted at blocks 4211, 4215, 4219, one or more adjusted bend plans maybe generated at block 4221, and the final adjusted bend plan may becomethe accepted bend plan. The resulting accepted bend plan may then beused to proceed with operations of blocks 4131, 4135, 4139, and/or 4141,which may be performed as discussed above with respect to FIG. 41 .

FIG. 43 illustrates operations of controller 102 according to stillother embodiments of inventive concepts.

At block 4301, processor 4007 may provide a first set of transformationpoints corresponding to respective attachment implants. Thetransformation points of the first set may be provided, for example,based on at least one of: optically capturing locations of attachmentimplants affixed to a patient using camera 114 (e.g., using a trackedprobe to point to attachment implants); locations of actual attachmentimplants in a medical image; and/or locations of virtual attachmentimplants in a medical image.

At block 4305, processor 4007 may generate a first bend plan for thesurgical rod based on the first set of transformation points. The firstbend plan, for example, may define a first plurality of bend angles atrespective bend positions along the surgical rod and correspondingrotational positions.

At block 4309, processor 4007 may provide a second set of transformationpoints corresponding to the respective attachment implants, with thefirst and second sets of transformation points being different. Thetransformation points of the second set may be provided, for example,based on at least one of: optically capturing locations of attachmentimplants affixed to a patient using camera 114 (e.g., using a trackedprobe to point to attachment implants); locations of actual attachmentimplants in a medical image; and/or locations of virtual attachmentimplants in a medical image. For example, the first set oftransformation points may be provided based on preoperative medicalimaging with virtual attachment implants (e.g., screws) placed therein,and the second set of transformation points may be provided based onintra-operative medical imaging after fixation of real/actual attachmentimplants (e.g., screws).

At block 4311, processor 4007 may generate a second bend plan for thesurgical rod based on the second set of transformation points, with thefirst and second bend plans being different. The second bend plan, forexample, may define a second plurality of bend angles at respective bendpositions along the surgical rod and corresponding rotational positions.

At block 4315, processor 4007 may generate a third bend plan for thesurgical rod based on merging the first and second bend plans and/orbased on merging the first and second sets of transformation points asdiscussed above, for example, with respect to FIG. 36 . In addition,processor 4007 may generate a third set of transformation points basedon merging the first and second sets of transformation points. Processor4007, for example, may generate the transformation points of the thirdset based on averaging/merging respective transformation points of thefirst and second sets and/or based on determining midpoints betweenrespective transformation points of the first and second sets. Processor4007 may then generate the third bend plan based on the third set oftransformation points. The third bend plan (also referred to as a mergedbend plan) may thus define a plurality of bend angles at respective bendpositions along the surgical rod and corresponding rotational positions.

At block 4325, processor 4007 generate an image output (provided throughoutput interface 4003 to display 118) to render the first, second, andthird bend plans on display 118 as discussed above, for example, withrespect to FIG. 36 .

As shown in embodiments of FIG. 36 , the image output may be generatedto render the first, second, and third sets of transformation points andthe respective first, second, and third bend plans in a first plane(e.g., the Sagittal plane) on a first portion of the display 118 and torender the first, second, and third sets of transformation points andthe respective first, second, and third bend plans in a second plane(e.g., the coronal plane) on a second portion of the display 118, withthe first and second planes being different (e.g., orthogonal). Inaddition, the image output may be generated to render the sets oftransformation points and the bend plans together with a medical image(e.g., a computed tomography CT scan image, an magnetic resonanceimaging MRI image, and/or a fluoroscopy image) on the display 118.Moreover, the image output may be generated to render the sets oftransformation points and the bend plans on the display 118 with amedical image including real/virtual attachment implants (e.g., screws).

At block 4319, processor 4007 may wait for user acceptance of the thirdbend plan before proceeding with operations of blocks 4131, 4135, 4139,and/or 4141. For example, processor 4007 may wait until user input isreceived (e.g., through a touch sensitive portion of display 118 orother user input device) to accept the third bend plan at block 4329.While not explicitly shown in FIG. 43 , operations similar to those ofFIG. 42 may allow the user to adjust one or more of the first, second,and/or third sets of transformation points that are used to generate therespective bend plans before accepting the third bend plan. Theresulting accepted bend plan may then be used to proceed with operationsof blocks 4131, 4135, 4139, and/or 4141, which may be performed asdiscussed above with respect to FIG. 41 .

FIG. 54 illustrates an embodiment of an autoclavable top assembly 121and motor housing 122 without a drape 1401 (e.g., see FIG. 14 ). Theautoclavable top assembly (or sterile mechanical housing) 121 (e.g., seeFIG. 3 ), comprises the mechanical components of the rod feedingsubassembly 104, brake subassembly 108 and bending subassembly 110. Theautoclavable top assembly 121 is configured to be removably coupled tothe motor housing (122, partially shown) so that the first and secondfeeding actuator motors 130, 132, brake actuator motor (not shown), andbending actuator motor 172 (e.g., see FIG. 3 ) may selectively operatethe rod feeding subassembly 104, brake subassembly 108, and bendingsubassembly 110, respectively. The autoclavable top assembly 121 mayhave shafts 160, 162, 168, 174 (e.g., see FIG. 3 ) with rotary seals(e.g., radial shaft seals). Rotary seals may be used to seal rotaryelements, such as a shaft or rotating bores against fluids, dust, dirt,etc. The rotary seals may create a barrier between surfaces whileallowing for rotary motion transfer. In some embodiments, the top plate5402 may be the bottom surface of the autoclavable top assembly 121,wherein the top plate 5402 may not have any other holes and may becompletely sealed.

The assembly operation of the autoclavable top assembly 121 may comprisea method comprising: 1) draping the motor housing (or non-autoclavableassembly) 122; 2) aligning the autoclavable top assembly 121 withrespect to the motor housing 122 using specific alignment features; 3)piercing the drape 1401 (e.g., see FIG. 14 ), wherein the piercing ofthe drape 1401 engages the shafts 160, 162, 168, 174 (e.g., see FIG. 3 )of the autoclavable top assembly 121 and motor housing 122; and 4)clamping the autoclavable top assembly 121 to the motor housing 122.According to some embodiments, there is a need for the aforestatedmethod steps to be carried out precisely, in order to ensure thatsterility is maintained throughout the assembly process.

However, in some instances, it may be challenging to precisely align theheavy, autoclavable top assembly 121 with respect to the motor housing122. In order to address this potential problem, alternative embodimentsthat may ensure that the entire assembly procedure is carried outautomatically is further presented herein. In the alternativeembodiments, the assembly process may be initiated and completed byelectronically initiating the action, thereby requiring minimal userinteraction. It should be noted that initiating the action may beaccomplished by any appropriate means, including the flipping of aswitch, pushing a button, or more sophisticated technologicalinterfaces, including, but not limited to selecting a command using acomputer mouse or by selecting a command on a touchscreen monitor.

The alternative embodiments presented herein may also ensure that agasket (e.g. gasket 2201 on FIG. 22 ) disposed about the periphery maybe compressed before the piercing of the drape (e.g., drape 1401 on FIG.14 ), for the purpose of maintaining the sterility of the system. Hence,the alternative embodiments may include methods comprising a linearactuated elevator assembly providing automatic positioning, and furthercomprising a clamping method which may contribute to and create astronger bond between the autoclavable top assembly 121 and the motorhousing 122. For example, embodiments comprising the linear actuatedelevator assembly may provide methods wherein shafts 160, 162, 168, 174(e.g., see FIG. 3 ) in the autoclavable top assembly 121 and within themotor housing 122, 5420 may be engaged by placing at least portions of amotion control system onto at least one pair of linear rails 5502 (e.g.,see FIG. 55 ), then electronically actuating the motion control systemusing a linear actuator 5410. The at least portions of a motion controlsystem may comprise at least portions of the linear actuated elevatorsystem disclosed herein, such as a linear actuator 5410, linear rails5502 (e.g., see FIG. 55 ), a cam assembly 5406, and a series ofattachment plates, including movable plates 5408.

With continued reference to FIG. 54 , the motor housing 122 may becovered with a sterile drape (e.g. drape 1401 on FIG. 14 ), while theautoclavable top assembly 121 may be exposed. As depicted in FIG. 54 ,the motor housing 122 may include a linear actuated elevator assemblycomprising at least one linear actuator 5410, at least one pair oflinear rails 5502 (e.g., see FIG. 55 ), two or more cam assemblies 5406,and a series of attachment plates, including a mid-plate 5404, and amoveable plate (or gearbox attachment plate) 5408. The motor housing 122may further include one or more spline shafts 5420, one or more splineshaft motors 5412 and a bending actuator motor 472.

FIG. 55 illustrates a rear view of a rod bender system comprising alinear actuated elevator system. The linear actuated elevator systemcomprises at least two linear rails 5502, at least one linear actuator5410, at least one cam assembly 5406, and a series of attachment plates,including a top plate 5402, a mid-plate 5404, and a movable plate 5408,that actuate with respect to each other in order to facilitate shaftengagement. As depicted, the autoclavable top assembly 121 may beremovably coupled to the mid-plate 5404 by way of the top plate 5402,which may be a bottom portion of the top assembly 121. The mid-plate5404 may be fixedly attached or coupled to the motor housing 122comprising the bottom non-autoclavable system. Various components,including but not limited to, spline motors (not shown), spline shafts5420, various electronic connectors and components of the linearactuated elevator system, including the linear actuator 5410 itself, maybe fixedly disposed on or removably coupled to the moveable plate 5408.The linear actuated elevator system provides a lifting means along thelongitudinal axis, in both the upward and downward directions, for themoveable plate 5408 and the components attached thereto.

The linear rails 5502 may be slidably disposed on a rear panel 5504 ofthe motor housing 122. At least one pair of linear rails 5502 may bedisposed along the longitudinal axis of the rear panel 5504 of the motorhousing 122, wherein the at least one pair of linear rails 5502 may bein parallel alignment with one another, and wherein the rear panel 5504of the motor housing may be slidably attached to the linear rails 5502by clamps 5506 or any appropriate connector that will allow the motorhousing 122 to move in the upward and downward directions with ease. Thelinear rails 5502 may provide low-friction guidance and high stiffnessfor loads of various sizes. The linear rails 5502 may provide theappropriate load capacity, travel accuracy, and rigidity. The linearrails 5502 may provide a high level of travel accuracy because ofprecise machining of one or both edges of the linear rails 5502. Linearrails 5502 may be suited for embodiments disclosed herein because oftheir ability to withstand moment loads. They may also accommodatetravel speeds up to 5 m/sec.

FIG. 56 illustrates an embodiment of a linear actuator 5410 according tosome embodiments of a linear actuated elevator system. The linearactuator 5410 may comprise a horizontal foot 5602, wherein thehorizontal foot 5602 may be disposed about the distal end 5622 of thelinear actuator 5410. The linear actuator 5410 may further comprise avertical shaft or leg 5604, wherein the vertical shaft or leg 5604 isfixedly attached to the horizontal foot 5602 at about a 90° angle, andwherein the terminal end of the vertical shaft or leg 5604 is disposedabout the proximal end 5620 of the linear actuator 5410. Moreover, afirst coupling device 5624 may be fixedly or removably disposed on theterminal end of the vertical shaft or leg 5604 at the proximal end 5620of the linear actuator 5410. A second coupling device 5626 may befixedly or removably disposed on the bottom of the horizontal foot 5602or at the distal end 5622 of the linear actuator 5410. The proximal end5620 of the linear actuator 5410 may be removably or fixedly attached tothe moveable plate 5408. The linear actuator 5410 may create motion in astraight line along the longitudinal axis, in contrast to the circularmotion of a conventional electric motor. In some embodiments, the motionof the linear actuator 5410 may be inherently produced by hydraulic orpneumatic cylinders.

Hydraulic actuators or hydraulic cylinders (not shown) may typicallyinvolve a hollow cylinder having a piston inserted in it. An unbalancedpressure applied to the piston (not shown) may generate force capable ofmoving the linear actuator 5410 in an upward and/or downward direction.Since liquids may be nearly incompressible, a hydraulic cylinder mayprovide controlled, precise linear displacement of the linear actuator5410. A pneumatic actuator may be similar to a hydraulic actuator,except pneumatic actuators use compressed gas to generate force insteadof a liquid.

In some embodiments, an electro-mechanical actuator may be used.Electro-mechanical actuators are similar to mechanical actuators, withthe exception of a control knob. The control knob may be replaced withan electric motor, wherein the rotary motor may be converted to lineardisplacement. Typically, an electric motor may be mechanically connectedto rotate a lead screw. The lead screw may have a continuous helicalthread machined on its circumference running along the length. A leadnut may be threaded onto the lead screw with corresponding helicalthreads. The lead nut may be prevented from rotating with the leadscrew. Therefore, when the lead screw is rotated, the lead nut may bedriven along the threads. The direction of motion of the lead nutdepends on the direction of rotation of the lead screw. By connectinglinkages to the lead nut, the motion may be converted to usable lineardisplacement.

FIG. 57 illustrates an embodiment of a cam system 5700 according to someembodiments of a linear actuated elevator system. As shown in FIG. 57 ,the cam system 5700 may be comprised of a cam engagement bar 5704, a camrotation center 5706, and a roller 5708. The cam system 5700 may becoupled to the movable 5408 at a distal end 5710 via a coupler 5712attached thereto. FIGS. 58A, 58B, and 58C illustrate variousconfigurations of a cam system 5700 according to some embodiments of alinear actuated elevator system. FIG. 58A depicts a first configuration,where the cam 5702 may be at ground position. FIG. 58B depicts a secondconfiguration, where the cam 5702 may lock onto the engagement bar 5704.FIG. 58C depicts a third configuration, where the cam roller 5708 maymove up to facilitate shaft engagement.

As depicted in FIGS. 58A-58C, the roller 5708 in the cam assembly 5700may connect to the moveable plate 5408. The engagement bar 5704 may beconnected to the top plate 5402. After the top plate assembly 121 hasbeen autoclaved, the entire top plate assembly 121 may be removeablycoupled onto the mid-plate 5404 using a kinematic mount (see FIG. 60 ).Then, the linear actuator 5410 may be activated using a switch (notshown). The switch used may be a mechanical switch appropriate for aspecific electronic circuit. For example, the mechanical switch may be asingle pole single throw (SPST), a single pole double throw (SPDT), adouble pole single throw (DPST), or a double pole double throw (DPDT).Moreover, the mechanical switch may be selected from the groupconsisting of a push button switch, toggle switch, limit switch, floatswitch, flow switch, pressure switch, temperature switch, joystickswitch, rotary switch, or combinations thereof. As the moveable plate5408 along the longitudinal axis, the roller 5708 may also moveaccordingly. The motion of the roller 5708 may push the cam surface 5702and may lead to the rotation of the cam 5702, as depicted in FIGS.58A-58C. For example, as the position of the roller 5708 moves from theconfiguration shown in FIG. 58A to the configuration shown in FIG. 58B,it may contact the cam 5702, moving it to a position whereby the cam5702 may lock onto the engagement bar 5704. Further, as the position ofthe roller 5708 moves from the configuration shown in FIG. 58B to theconfiguration shown in FIG. 58C, the roller 5702 may move in arelatively straight line, which may subsequently lead to drape piercingand spline shaft engagement, as shown in FIGS. 59A-59C.

FIGS. 59A-59C depict the various positions of an embodiment of amoveable plate 5408 relative to the corresponding cam positions as shownin FIGS. 58A-58C. The roller 5708 may also open the cam 5702, as theroller 5708 travels downward. Strike points (not shown) between theroller 5708 and the cam 5702 may contribute to the opening and closingof the cam 5702, as depicted in FIGS. 59A-59C. It should be noted thatthe motion, which includes the opening and closing of the cam 5702, mayoccur while the drape 1401 (e.g., see FIG. 14 ) is engaged between thetop plate 5402 and the mid-plate 5404. The spline shafts 5420 may have adistal end (not shown) and a proximal end 5430, wherein the proximal end5430 may be designed to pierce through the drape 1401. For example, insome embodiments the proximal end 5430 may be designed as a pointed end.

The method comprising movement of the cam 5702 may comprise a first stepof engaging and locking the top plate 5402 with the motor housing 122; asecond step of piercing the spline shafts 5420 through the drape; athird step of engaging the spline shaft 5420; and a fourth step ofreleasing the top plate 5402 automatically after the cam roller 5708begins moving in a downward direction. The first step of engaging andlocking the top plate 5402 with the motor housing 122 may prevent topplate 5402 separation from the motor housing 122 during operation. Thesecond step of piercing the spline shafts 5420 through the drape 1401may comprise automatic piercing of the drape 1401, wherein the automaticpiercing of the drape 1401 may result in a uniform cut in the drape1401.

FIG. 60 illustrates kinematic mounts 6002 for mounting an embodiment ofa top plate 5402 onto an embodiment of a mid-plate 5404 according tosome embodiments of a linear actuated elevator system. FIG. 60 shows theengagement of an embodiment of the top plate 5402 and the mid-plate 5404through mating the kinematic mounts or couplings 6002. The kinematiccouplings 6002 may contribute to precise alignment of the top plate 5402with respect to the mid-plate 5404 with repeatability. The kinematiccouplings 6002 may also contribute to ease of alignment of the top plate5402 with respect to the mid-plate 5404, by comparison to otheralignment features such as dowel pins or reference edges. FIGS. 61A and61B illustrate an embodiment having a kinematic mount 6002 employing aseries of v-grooves 6104 and hemispheres 6102. The kinematic coupling6002 may comprise three radial v-grooves 6104 in one part that mate withthree hemispheres 6102 in another part. Each hemisphere 6102 can havetwo contact points for a total of six contact points, for the purpose ofconstraining all six of the top and the mid plates 5402, 5404 degrees offreedom. An alternative embodiment may comprise of three hemispheres6102 on either the top plate 5402 or the mid-plate 5404 that fitrespectively into a tetrahedral dent, a v-groove 6104 and a flatdisposed on the opposing plate. The series of v-grooves 6104 andhemispheres 6102 create a precision alignment. As shown in FIGS. 61A and61B, after placing the top plate 5402 onto the mid-plate 5404, thehemispheres or ball-end surfaces 6102 may be forced to slide into thev-grooves 6104.

The linear actuated elevator assembly may provide advantages thatcomprise at least the following 1) piercing the drape automatically,wherein the automatic piercing may ensure that the sterility of the topassembly 122 is maintained throughout the assembly procedure; 2)clamping and aligning the spline shaft 5420 automatically, wherein theautomatic clamping and aligning may decrease the possibility of usererror; 3) actuating the motor housing 122 automatically, wherein theautomatic actuating of the motor housing 122 may simplify the use andoperation of the system; and 4) aligning the top and bottom plates 5402,5404 with kinematic couplings 6002, wherein the aligning with kinematiccouplings 6002 may allow for ease of alignment, particularly forembodiments with heavy, top plates 5402.

FIG. 62 is a flowchart of a method of operating a bending robot 100comprising a linear actuated elevator assembly, according to someembodiments. The operations 6200 include sterilizing a first housingcomprising a rod feeding subassembly, a brake subassembly, and a bendingsubassembly (Block 6202). The operations 6200 further include initiatinga linear actuated elevator assembly configured to automaticallyremovably couple the first housing to a second housing comprising amotor configured to selectively operate the feeding subassembly,selectively operating the brake subassembly, and selectively operatingthe bending subassembly (Block 6204). The operations 6200 furtherinclude retaining a surgical rod in a rod feeding subassembly (Block6206) and causing a feeding actuator of the rod feeding subassembly toselectively move the surgical rod in a direction parallel to alongitudinal axis of the surgical rod (Block 6208). The operations 6200further include causing the feeding actuator to selectively rotate in asurgical rod about the longitudinal axis of the surgical rod (Block6210), and receiving the surgical rod in the brake feeding subassemblyfrom the rod feeding subassembly (Block 6212). The operations 6200further include causing a brake actuator of the brake subassembly toselectively fix a first portion of the surgical rod with respect to thebrake subassembly (Block 6214). The operations 6200 further includecausing a bending actuator of the bending subassembly to selectivelyrotate about a first rotational axis perpendicular to the longitudinalaxis of the surgical rod, wherein rotating the bending actuator causesthe bending actuator to engage a second portion of the rod and bend thesecond portion of the rod with respect to the first portion of thesurgical rod so that the first portion and the second portion of thesurgical rod define a first bend angle (Block 6216). The operations 6200further include causing a blade of the brake subassembly to selectivelycut the surgical rod.

In the above description of various embodiments of present inventiveconcepts, it is to be understood that the terminology used herein is forthe purpose of describing particular embodiments only and is notintended to be limiting of present inventive concepts. Unless otherwisedefined, all terms (including technical and scientific terms) usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which present inventive concepts belong. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of this specification andthe relevant art and will not be interpreted in an idealized or overlyformal sense unless expressly so defined herein.

When an element is referred to as being “connected”, “coupled”,“responsive”, or variants thereof to another element, it can be directlyconnected, coupled, or responsive to the other element or interveningelements may be present. In contrast, when an element is referred to asbeing “directly connected”, “directly coupled”, “directly responsive”,or variants thereof to another element, there are no interveningelements present. Like numbers refer to like elements throughout.Furthermore, “coupled”, “connected”, “responsive”, or variants thereofas used herein may include wirelessly coupled, connected, or responsive.As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. Well-known functions or constructions may not be described indetail for brevity and/or clarity. The term “and/or” includes any andall combinations of one or more of the associated listed items.

It will be understood that although the terms first, second, third, etc.may be used herein to describe various elements/operations, theseelements/operations should not be limited by these terms. These termsare only used to distinguish one element/operation from anotherelement/operation. Thus a first element/operation in some embodimentscould be termed a second element/operation in other embodiments withoutdeparting from the teachings of present inventive concepts. The samereference numerals or the same reference designators denote the same orsimilar elements throughout the specification.

As used herein, the terms “comprise”, “comprising”, “comprises”,“include”, “including”, “includes”, “have”, “has”, “having”, or variantsthereof are open-ended, and include one or more stated features,integers, elements, steps, operations, components, functions or groupsbut do not preclude the presence or addition of one or more otherfeatures, integers, elements, steps, operations, components, functionsor groups thereof. Furthermore, as used herein, the common abbreviation“e.g.”, which derives from the Latin phrase “exempli gratia,” may beused to introduce or specify a general example or examples of apreviously mentioned item, and is not intended to be limiting of suchitem. The common abbreviation “i.e.”, which derives from the Latinphrase “id est,” may be used to specify a particular item from a moregeneral recitation.

Example embodiments are described herein with reference to blockdiagrams and/or flowchart illustrations of computer-implemented methods,apparatus (systems and/or devices) and/or computer program products. Itis understood that a block of the block diagrams and/or flowchartillustrations, and combinations of blocks in the block diagrams and/orflowchart illustrations, can be implemented by computer programinstructions that are performed by one or more computer circuits. Thesecomputer program instructions may be provided to a processor circuit(also referred to as a processor) of a general purpose computer circuit,special purpose computer circuit, and/or other programmable dataprocessing circuit to produce a machine, such that the instructions,which execute via the processor of the computer and/or otherprogrammable data processing apparatus, transform and controltransistors, values stored in memory locations, and other hardwarecomponents within such circuitry to implement the functions/actsspecified in the block diagrams and/or flowchart block or blocks, andthereby create means (functionality) and/or structure to implement thefunctions/acts/operations specified in the block diagrams and/orflowchart block(s).

These computer program instructions may also be stored in a tangiblecomputer-readable medium that can direct a computer or otherprogrammable data processing apparatus to function in a particularmanner, such that the instructions stored in the computer-readablemedium produce an article of manufacture including instructions whichimplement the functions/acts specified in the block diagrams and/orflowchart block or blocks. Accordingly, embodiments of present inventiveconcepts may be embodied in hardware and/or in software (includingfirmware, resident software, micro-code, etc.) that runs on a processorsuch as a digital signal processor, which may collectively be referredto as “circuitry,” “a module” or variants thereof.

It should also be noted that in some alternate implementations, thefunctions/acts noted in the blocks may occur out of the order noted inthe flowcharts. For example, two blocks shown in succession may in factbe executed substantially concurrently or the blocks may sometimes beexecuted in the reverse order, depending upon the functionality/actsinvolved. Moreover, the functionality of a given block of the flowchartsand/or block diagrams may be separated into multiple blocks and/or thefunctionality of two or more blocks of the flowcharts and/or blockdiagrams may be at least partially integrated. Finally, other blocks maybe added/inserted between the blocks that are illustrated, and/orblocks/operations may be omitted without departing from the scope ofinventive concepts. Moreover, although some of the diagrams includearrows on communication paths to show a primary direction ofcommunication, it is to be understood that communication may occur inthe opposite direction to the depicted arrows.

Although several embodiments of inventive concepts have been disclosedin the foregoing specification, it is understood that many modificationsand other embodiments of inventive concepts will come to mind to whichinventive concepts pertain, having the benefit of teachings presented inthe foregoing description and associated drawings. It is thus understoodthat inventive concepts are not limited to the specific embodimentsdisclosed hereinabove, and that many modifications and other embodimentsare intended to be included within the scope of the appended claims. Itis further envisioned that features from one embodiment may be combinedor used with the features from a different embodiment(s) describedherein. Moreover, although specific terms are employed herein, as wellas in the claims which follow, they are used only in a generic anddescriptive sense, and not for the purposes of limiting the describedinventive concepts, nor the claims which follow. The entire disclosureof each patent and patent publication cited herein is incorporated byreference herein in its entirety, as if each such patent or publicationwere individually incorporated by reference herein. Various featuresand/or potential advantages of inventive concepts are set forth in thefollowing claims.

What is claimed is:
 1. A robotic rod bender comprising: an autoclavabletop assembly comprising a rod feeding subassembly configured to feed asurgical rod, a brake subassembly configured to receive the rod from therod feeding subassembly and fix the surgical rod in place, and a bendingsubassembly configured to bend the surgical rod while the surgical rodis fixed in place by the brake subassembly; wherein the rod feedingsubassembly, the bending subassembly, and the brake subassembly aredisposed on a top plate; and a motor housing comprising one or moremotors configured to drive the autoclavable top assembly, a splineshaft, and a linear actuated elevator assembly, wherein the linearactuated elevator assembly is configured to move upward and downwardalong a longitudinal axis, wherein the linear actuated elevator assemblycomprises a linear actuator, a movable plate, and a mid-plate above themovable plate, wherein the spline shaft extends from the moveable plateand wherein at least one of the motors is connected to the moveableplate; wherein the autoclavable top assembly is disposed atop themid-plate; and wherein the linear actuated elevator assembly providesautomatic positioning of one or more components of the motor housingwith the autoclavable top assembly.
 2. The robotic rod bender of claim 1wherein linear actuated elevator assembly further comprises a camassembly, the cam assembly comprising a cam, a roller, and a camengagement bar, wherein the roller is connected to the movable plate,and wherein the cam engagement bar is connected to the top plate.
 3. Therobotic rod bender of claim 2 wherein the linear actuator is removablyattached to the movable plate, wherein the linear actuator is configuredto lift the moveable plate upward along the longitudinal axis, whereinthe roller is configured to move in conjunction with the movable plate,and wherein the roller is configured to contact and rotate the cam,thereby causing the cam to engage with and lock onto the cam engagementbar, and wherein the roller is configured to continue to move in astraight line along the longitudinal axis, wherein the rollerfacilitates automatic piercing of a drape and engaging the spline shaft.4. The robotic rod bender of claim 3 wherein the automatic positioningof the motor housing with the autoclavable top assembly comprisesalignment of the autoclavable top assembly with respect to the motorhousing.
 5. The robotic rod bender of claim 2 wherein the cam has afirst configuration, wherein the first configuration is a groundposition.
 6. The robotic rod bender of claim 5 wherein the cam has asecond configuration, wherein the cam locks onto the cam engagement bar.7. The robotic rod bender of claim 6 wherein the cam has a thirdconfiguration, wherein the roller moves along the longitudinal axis tofacilitate engagement with the spline shaft.
 8. The robotic rod benderof claim 1 wherein the linear actuated elevator assembly furthercomprises at least one pair of linear rails positioned in parallelalignment with one another, wherein the linear rails are disposed alongthe longitudinal axis, wherein the linear rails are configured tofacilitate movement of the motor housing in an upward and downwarddirection.
 9. The robotic rod bender of claim 1 wherein the spline shaftengages with the mid-plate.
 10. The robotic rod bender of claim 1wherein the linear actuator is activated with a switch.
 11. The roboticrod bender of claim 1 wherein the top plate is coupled to the mid-platewith a kinematic mount.
 12. A motor housing for a robotic rod bendercomprising: a motor; a spline shaft; a linear actuated elevator assemblycomprising: a mid-plate; a movable plate below the mid-plate, whereinthe motor is connected to the moveable plate, and wherein the splineshaft extends from the moveable plate; a cam assembly comprising a cam,a roller, and a cam engagement bar, wherein the roller is connected tothe movable plate, wherein the cam engagement bar is connected to a topplate, wherein the roller is configured to move in conjunction with themovable plate, wherein the roller is further configured to contact androtate the cam, thereby causing the cam to engage with and lock onto thecam engagement bar, and wherein the roller is further configured tocontinue to move in a straight line along a longitudinal axis of themotor housing, and wherein the roller facilitates automatic piercing ofa drape and engaging the spline shaft through the mid-plate, at leastone pair of linear rails positioned in parallel alignment with oneanother, wherein the linear rails are disposed along the longitudinalaxis, wherein the linear rails are configured to facilitate movement ofthe moveable plate in an upward and a downward direction; and a linearactuator removably attached to the movable plate, wherein activation ofthe linear actuator is configured to lift the movable plate upward alongthe longitudinal axis.
 13. The motor housing of claim 12 wherein thespline shaft comprises a central projection that engages with themid-plate.
 14. The motor housing of claim 13 wherein the cam has a firstconfiguration, wherein the first configuration is a ground position. 15.The motor housing of claim 14 wherein the cam has a secondconfiguration, wherein the cam locks onto the cam engagement bar. 16.The motor housing of claim 15 wherein the cam has a third configuration,wherein the roller moves along the longitudinal axis to facilitateengagement with the spline shaft.
 17. The motor housing of claim 12wherein the linear actuator is activated with a switch.
 18. The motorhousing of claim 12 wherein the top plate is coupled to the mid-platewith a kinematic mount.
 19. The motor housing of claim 12 wherein themoveable plate is positionable to align one or more components of themotor housing with respect to the top plate.
 20. The motor housing ofclaim 19 wherein the motor housing is configured for clamped engagementwith the top plate.